Devices, systems and methods for locating and interacting with medicament delivery systems

ABSTRACT

In some embodiments, a method includes producing, from an adapter, a first wireless signal characterized by a first communication mode with a computing device when a portion of at least one of a medicament delivery device or a simulated medicament delivery is disposed within the adapter. An indication is received when the portion of the medicament delivery device or the simulated medicament delivery device is removed from the adapter. A second wireless signal characterized by a second communication mode with the computing device is produced in response to the indication. The second communication mode is different from the first communication mode. The second communication mode can be, for example, a hold mode, a sniff mode or a park mode.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 61/746,308, entitled “Devices, Systems and Methods for Locating andInteracting with Medicament Delivery Systems,” filed Dec. 27, 2012,which is incorporated herein by reference in its entirety.

BACKGROUND

The embodiments described herein relate generally to a medical device,and more particularly to a medicament delivery device, and/or asimulated medicament delivery device having and/or associated with awireless communication module. The embodiments described herein alsorelate to devices for interacting with and/or monitoring (e.g.,wirelessly) with such medicament delivery devices and/or simulatedmedicament delivery devices via the wireless communication module.

Exposure to certain substances, such as, for example, peanuts,shellfish, bee venom, certain drugs, toxins, and the like, can causeallergic reactions in some individuals. Such allergic reactions can, attimes, lead to anaphylactic shock, which can cause a sharp drop in bloodpressure, hives, and/or severe airway constriction. Accordingly,responding rapidly to mitigate the effects from such exposures canprevent injury and/or death. For example, in certain situations, aninjection of epinephrine (i.e., adrenaline) can provide substantialand/or complete relief from the allergic reaction. In other situations,for example, an injection of an antidote to a toxin can greatly reduceand/or eliminate the harm potentially caused by the exposure. Becauseemergency medical facilities may not be available when an individual issuffering from an allergic reaction, some individuals carry a medicamentdelivery device, such as, for example, an auto-injector, to rapidlyself-administer a medicament in response to an allergic reaction.

As another example, naloxone is a medicament that prevents and/orreverses the effects of opioids. Known formulations of naloxone can beused, for example, to treat respiratory depression and other indicationsthat result from opioid toxicity. For example, known formulations fornaloxone can be used to reverse and/or mitigate the effects of anoverdose of a drug containing opioids, such as, for example,prescription opioids like oxycodone or illicit opioids like heroin. Insuch situations, it is desirable to deliver the naloxone formulationquickly and in a manner that will produce a rapid onset of action. Knownmethods for delivering naloxone intranasally or via injection, however,often involve completing a series of operations that, if not doneproperly, can limit the effectiveness of the naloxone formulation.Moreover, because naloxone is often administered during an emergencysituation, even experienced and/or trained users may be subject toconfusion and/or panic, thereby compromising the delivery of thenaloxone formulation.

As yet another example, glucagon is a medicament that is administered totreat patients suffering from hypoglycemia. In certain situations, theonset of hypoglycemia can cause the patient to lose motor coordinationand/or lose consciousness. Thus, glucagon is often administered by acare giver during an emergency situation.

In the above-identified examples, the individual requiring themedicament may be inexperienced and/or may infrequently require medicalintervention (e.g., in the case of a naloxone delivery device), and thusmay be forget to carry the medicament delivery device and/or forget howto use the delivery device. For example, to actuate some knownauto-injectors, the user may be required to execute a series ofoperations. For example, to actuate some known auto-injectors, the usermust remove a protective cap, remove a locking device, place theauto-injector in a proper position against the body and then press abutton to actuate the auto-injector. Failure to complete theseoperations properly can result in an incomplete injection and/orinjection into an undesired location of the body. If the medicamentdelivery device is not available or if the individual is unable toproperly operate the medicament delivery device, important medical aidmay not be properly delivered.

The likelihood of improper use of known medicament delivery devices canbe compounded by the nature of the user and/or the circumstances underwhich such devices are used. For example, many users are not trainedmedical professionals and may have never been trained in the operationof such devices. Moreover, in certain situations, the user may not bethe patient, or primary care-giver, and may therefore have no experiencewith the medicament delivery device. Similarly, because some knownmedicament delivery devices are configured to be used relativelyinfrequently in response to an allergic reaction or the like, even thoseusers familiar with the device and/or who have been trained may not bewell practiced at operating the device. Finally, such devices are oftenused during an emergency situation, during which even experienced and/ortrained users may be subject to confusion, panic, and/or thephysiological effects of the condition requiring treatment.

Additionally or alternatively, the individual requiring the medicamentmay be incapacitated and unable to inform bystanders of the nature ofthe medical emergency, that a medicament delivery device is available,and/or how to use the medicament delivery device. If bystanders remainunaware of the availability and location of the medicament deliverydevice, or are unable to administer the medicament, important medicalaid may not be delivered. To enhance the likelihood of proper use, someknown medicament delivery devices include printed instructions to informthe user of the steps required to properly deliver the medicament. Suchprinted instructions, however, can be inadequate for the class of usersand/or the situations described above. Moreover, because some knownmedicament delivery devices, such as, for example, auto-injectors, peninjectors, nasal delivery systems, wearable injectors or bolus pumps,transdermal delivery systems, inhalers or the like, can be compact, suchprinted instructions may be too small to read and comprehend during asituation requiring the need for immediate and accurate administration.

Furthermore, some known medicament delivery devices, such as, forexample, auto-injectors, pen injectors, inhalers, and/or simulatedmedicament delivery devices are configured to be carried with the user.Although such devices may improve the likelihood of compliance, suchportable devices can exacerbate the shortcomings described above (e.g.,inadequate instructions for use). Additionally, because such portabledevices are small, there is an increased likelihood that such deviceswill be forgotten and/or misplaced. Moreover, the cost and sizeconstraints of known devices prevents the inclusion of more detailedfeatures to address the shortcomings described herein. As one example,such portable medicament delivery devices may have limited space forelectronics. For example, unlike stationary devices, such as infusionpumps and the like, compact medicament delivery devices may haveinsufficient space for full-scale computational devices, such as generalpurpose processors, large form-factor printed circuit boards, and thelike.

In addition to the issues relating to improper use of medicamentdelivery devices, monitoring the patient's compliance with knownmedicament delivery devices can also be problematic. For example, someknown treatment regimens include multiple doses of a medicament thatmust be administered in a timely fashion and/or in a particular order toensure effectiveness (e.g., certain vaccination regimens). Thus,monitoring the patient's compliance is an important aspect in ensuringthat the treatment method will be effective. Some known medicamentdelivery systems include a medicament delivery device and anaccompanying electronic system to assist the user in setting the properdosage and/or maintaining a compliance log. Such known medicamentdelivery systems and the accompanying electronic systems can be largeand therefore not conveniently carried by the user. Such knownmedicament delivery systems and the accompanying electronic systems canalso be complicated to use and/or expensive to manufacture.

In addition, an extended shelf life may be desirable for some medicamentdelivery devices, such as devices intended to be carried by a user on adaily basis. For example, an auto-injector intended to be carried by auser on a daily basis may be expected to work after weeks, months, oryears without user maintenance. As another example, known emergency-useauto-injectors are single-use devices that are expected to be carriedfor years before a potential use. The disposable nature and/or extendedshelf-life of such devices can further exacerbate the shortcomingsdescribed above. For example, the electronics of known stationarydevices, particularly known devices having electronic communicationmeans (e.g., for compliance tracking), may not be efficient enough toprovide sufficiently long battery life for use in a portable, extendedshelf life device. Furthermore, efficient power management may bedesirable to extend the useful life of a medicament delivery device,particularly for a device having limited battery capacity, limited or nouser replaceable batteries, and/or limited or no charging capacity.

As another way to enhance the likelihood of proper use, some knownmedicament delivery devices are associated with simulated medicamentdelivery devices (e.g., “trainers”) to provide a method for users topractice using the medicament delivery device without being exposed tothe medicament and/or needles typically contained therein. Suchsimulated medicament delivery devices, however, can also includeinadequate use instructions as described above.

Thus, a need exists for medicament delivery systems and/or devices thatallow a medicament delivery device to be quickly identified and located,alert the user if the medicament delivery device is forgotten, andprovide instructions that can be easily understood by a user in any typeof situation. Additionally, a need exists for simulated medicamentdelivery systems and/or devices that can provide instructions and thatcan be reused multiple times. Moreover, a need exists for medicamentdelivery systems and/or devices that can provide compliance informationassociated with the use of the device and/or that can communicateelectronically with other communications devices.

SUMMARY

System and methods to facilitate wireless communications with medicamentdelivery devices and simulated medicament delivery devices are describedherein. In some embodiments, a method includes producing, from anadapter, a first wireless signal characterized by a first communicationmode with a computing device when a portion of at least one of amedicament delivery device or a simulated medicament delivery isdisposed within the adapter. An indication is received when the portionof the medicament delivery device or the simulated medicament deliverydevice is removed from the adapter. A second wireless signalcharacterized by a second communication mode with the computing deviceis produced in response to the indication. The second communication modeis different from the first communication mode. The second communicationmode can be, for example, a hold mode, a sniff mode or a park mode.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of medicament delivery systemaccording to an embodiment of the invention.

FIG. 2 is a schematic illustration of processor used to perform themethods described, according to an embodiment.

FIGS. 3 and 4 are perspective views of a medical injector according toan embodiment of the invention, in a first configuration.

FIG. 5 is a front view of the medical injector illustrated in FIG. 3with the cover removed.

FIG. 6 is a back view of the medical injector illustrated in FIG. 3 withthe cover removed.

FIG. 7 is a front view of a portion of the medical injector illustratedin FIG. 3.

FIG. 8 is a perspective view of a portion of the medical injectorillustrated in FIG. 3.

FIG. 9 is a bottom perspective view of a housing of the medical injectorillustrated in FIG. 3.

FIG. 10 is a top perspective view of a housing of the medical injectorillustrated in FIG. 3.

FIG. 11 is a perspective view of a proximal cap of the medical injectorillustrated in FIG. 3.

FIG. 12 is a front view of a medicament delivery mechanism of themedical injector illustrated in FIG. 3.

FIG. 13 is a back view of an electronic circuit system of the medicalinjector illustrated in FIG. 3.

FIG. 14 is a front view of a portion of the electronic circuit system ofthe medical injector illustrated in FIG. 13.

FIG. 15 is a side view of the electronic circuit system of the medicalinjector illustrated in FIG. 13.

FIG. 16 is a front view of an electronic circuit system housing of themedical injector illustrated in FIG. 13.

FIG. 17 is a perspective view of the electronic circuit system housingof the medical injector illustrated in FIG. 16.

FIG. 18 is a perspective view of a battery clip of the medical injectorillustrated in FIG. 13.

FIG. 19 is a perspective view of a portion of an electronic circuitsystem of the medical injector illustrated in FIG. 3, in a firstconfiguration.

FIG. 20 is a front view of the medical injector illustrated in FIG. 3 ina first configuration showing the electronic circuit system.

FIGS. 21, 22, and 23 are front views of a portion of the electroniccircuit system of the medical injector labeled as Region Z in FIG. 20 ina first configuration, a second configuration, and a thirdconfiguration, respectively.

FIGS. 24 and 25 are perspective views of a cover of the medical injectorillustrated in FIG. 3.

FIG. 26 is a perspective view of a safety lock of the medical injectorillustrated in FIG. 3.

FIG. 27 is a front view of the safety lock of the medical injectorillustrated in FIG. 26.

FIG. 28 is a bottom view of the safety lock of the medical injectorillustrated in FIG. 26.

FIG. 29 is a perspective view of a needle sheath of the safety lock ofthe medical injector illustrated in FIG. 26.

FIG. 30 is a perspective view of a base of the medical injectorillustrated in FIG. 3.

FIG. 31 is a front view of the base of the medical injector illustratedin FIG. 3.

FIG. 32 is a back view of the medical injector illustrated in FIG. 3 ina second configuration.

FIG. 33 is a back view of the medical injector illustrated in FIG. 3 ina third configuration.

FIG. 34 is a back view of the medical injector illustrated in FIG. 3 ina fourth configuration.

FIG. 35 is a schematic diagram of a monitor device, an adapter, and amedicament delivery device according to an embodiment.

FIG. 36 is a schematic diagram of a locator device, a medicamentdelivery device and a medicament container according to an embodiment.

FIG. 37 is a front view of a cover having an electronic circuit system,according to an embodiment.

FIGS. 38 and 39 are a signal diagrams representing communicationsbetween a patient, a monitoring device, a communication device, alocator device, a medicament delivery device, and a user according to anembodiment.

FIGS. 40 through 42 are isometric views of a kit containing a medicamentcontainer in a first configuration, a second configuration and a thirdconfiguration, respectively, according to an embodiment.

FIG. 43 is a schematic diagram showing the interactions between apatient/user, a medicament delivery device, a docking case, acommunication device, and a communication network according to anembodiment.

FIGS. 44 and 45 are schematic diagrams of a docking case coupled to amedicament delivery device and a communication device in a firstconfiguration and a second configuration, respectively, according to anembodiment.

FIGS. 46 and 47 are flow charts of methods associated with monitoring anadapter, according to two embodiments.

FIG. 48 is a flow chart of a method of using a simulated medicamentdelivery device, according to an embodiment.

FIGS. 49-51 are screenshots of a user interface associated with methods,according to three embodiments.

DETAILED DESCRIPTION

This application describes devices that are related to and/or can beused with the devices and systems described in U.S. Pat. No. 8,172,082,entitled “Devices Systems and Methods for Medicament Delivery,” filedFeb. 5, 2007, U.S. Pat. No. 8,231,573, entitled “Medicament DeliveryDevice Having an Electronic Circuit System,” filed May 12, 2008, andU.S. Pat. No. 8,361,026, entitled Apparatus and Methods forSelf-Administration of Vaccines and Other Medicaments,” filed Nov. 10,2009, each of which is incorporated herein by reference in its entirety.

The medicament delivery systems shown and described herein can be usedin conjunction with any suitable medicament delivery device and/ormedicament container such that the medicament delivery device and/ormedicament container can be easily accessed, identified and located, asdescribed herein. In some embodiments, the medicament delivery devicecan be a medical injector, such as a pen injector, a prefilled syringe,an auto-injector, nasal delivery device or the like.

In some embodiments, an apparatus includes a medicament delivery deviceand an electronic circuit system. The electronic circuit system includesa radio such that the apparatus can be electronically linked to acomputing device using a wireless protocol. The medicament deliverydevice can have a first configuration and a second configuration. Theradio can send a signal characterized by a first communication intervalwhen the medicament delivery device is in the first configuration. Theradio can send a signal characterized by a second, different,communication interval when the medicament delivery device is in thesecond configuration.

In some embodiments, a method includes producing a first wireless signalcharacterized by a first communication interval when a medicamentdelivery device is in a first configuration. An indication can bereceived indicating that the medicament delivery device has transitionedfrom the first configuration to a second configuration. A secondwireless signal, characterized by a second, different, communicationinterval can be sent in response to receiving the indication that themedicament delivery device has transitioned from the first configurationto a second configuration. In some embodiments, the first communicationinterval is associated with a first communication mode, and the secondcommunication interval is associated with a second communication mode.The first communication mode and/or the second communication mode can bean advertising mode, a hold mode, a sniff mode or a park mode.

In some embodiments, a non-transitory processor-readable medium includescode to cause a processor of a device to produce a first wireless signalcharacterized by a first communication interval when a medicamentdelivery device is in a first configuration. The non-transitoryprocessor-readable medium includes code to receive an indication thatthe medicament delivery device has transitioned from the firstconfiguration to a second configuration. The code (executed on aprocessor) can cause the device to produce a second wireless signal,characterized by a second, different, communication interval in responseto receiving the indication that the medicament delivery device hastransitioned.

In some embodiments, an apparatus includes a radio, a memory and acommunication module. The radio is configured to electronicallycommunicate with a computing device via a wireless protocol (e.g.,Bluetooth®). The radio is configured to send a first wireless signalassociated with a first communication interval and a second wirelesssignal associated with a second communication interval. The memory isconfigured to store transition information associated with a transitionof a medicament delivery device from a first configuration to a secondconfiguration. The communication module, which is implemented in atleast one of the memory or a processing device, is configured to receivethe transition information and determine, based on the transitioninformation, at least the second communication interval.

In some embodiments, an apparatus includes an adapter configured toreceive at least a portion of a medicament delivery device or asimulated medicament delivery device. The apparatus also includes anelectronic circuit system having a sensor and a radio. The sensor candetect when the adapter is removed from the medicament delivery deviceor the simulated medicament delivery device. The radio canelectronically communicate with a computing device via a wirelessprotocol. The radio can send a first signal characterized by a firstcommunication interval when the adapter is coupled to the medicamentdelivery device or the simulated medicament delivery device, and cansend a second signal characterized by a second communication intervalwhen the adapter is not coupled to the medicament delivery device or thesimulated medicament delivery device. In some such embodiments, themedicament delivery device or the simulated medicament delivery caninclude a second electronic circuit system configured to produce anelectronic output when the medicament delivery device or the simulatedmedicament delivery device is actuated. In such embodiments, the adaptercan include a protrusion that can isolate the circuit of the medicamentdelivery device or the simulated medicament delivery device from abattery when the adapter is coupled to the medicament delivery device ora simulated medicament delivery device.

In some embodiments, an apparatus includes an adapter configured toreceive at least a portion of a medicament delivery device or asimulated medicament delivery device. The medicament delivery device orthe simulated medicament delivery device includes a first electroniccircuit system configured to produce an electronic output when thedevice is actuated. The adapter has a protrusion configured to isolateat least a portion of the first electronic circuit system from a powersource when the portion of the at least one of the medicament deliverydevice or the simulated medicament delivery device is disposed withinthe adapter. The apparatus further includes a second electronic circuitsystem coupled to the adapter. The second electronic circuit systemincludes a radio configured to electronically communicate with acomputing device via a wireless protocol. The radio is configured tosend a first signal when the portion of the medicament delivery deviceor the simulated medicament delivery device is within the adapter and asecond signal when the portion of the medicament delivery device or thesimulated medicament delivery device is spaced apart from the adapter,the second signal different from the first signal.

In some embodiments, a method includes producing, from an adapter, afirst wireless signal characterized by a first communication mode with acomputing device when a portion of at least one of a medicament deliverydevice or a simulated medicament delivery is disposed within theadapter. An indication is received when the portion of the medicamentdelivery device or the simulated medicament delivery device is removedfrom the adapter. A second wireless signal characterized by a secondcommunication mode with the computing device is produced in response tothe indication. The second communication mode is different from thefirst communication mode. The second communication mode can be, forexample, a hold mode, a sniff mode or a park mode.

In some embodiments, a simulated medicament delivery device can producean indication associated with an operation of the simulated medicamentdelivery device. In response, a recorded speech output can be generatedand information associated with the operation can be stored in a memory.A training script can be updated based on the information stored in thememory.

In some embodiments, a method includes receiving an indicationassociated with an operation from a set of operations associated with asimulated medicament delivery device. The set of operations can be, forexample, a series of operations to be taken when actuating an actualmedicament delivery device that corresponds to the simulated device. Inresponse to the indication, a recorded speech output associated with afirst training script is produced. Additionally, in response to theindication, use information associated with the plurality of operationsassociated with a simulated medicament delivery device is updated. Themethod further includes producing, in response to the updated useinformation, a second training script.

In some embodiments, a method includes receiving at a first time awireless signal associated with a slave device. A first locationassociated with a master device at the first time is determined. Analarm is produced when the wireless signal is not received within a timeperiod after the first time and a second location associated with themaster device at a second time is different from the first location by adistance.

The term “about” when used in connection with a referenced numericindication means the referenced numeric indication plus or minus up to10% of that referenced numeric indication. For example, “about 100”means from 90 to 110.

FIG. 1 is a schematic illustration of a medicament delivery system 1000(also referred to herein simply as “the system 1000”) according to anembodiment. The system 1000 includes a medicament delivery device 1100,an adapter 1210, a computing device 1510, and a remote device 1610.

The medicament delivery device 1100 can be any of the medicamentdelivery devices described herein. The medicament delivery device 1100can be any of the medicament delivery devices described in furtherdetail herein. For example, the medicament delivery device 1100 can bean auto-injector similar to the auto-injector 4000 described below withreference to FIGS. 3-34. In other embodiments, the medicament deliverydevice can be a pen-injector, a syringe, a nasal delivery device (such anasal spray device), an inhaler, etc. In yet other embodiments, thedevice 1100 can be a simulated medicament delivery device (i.e., adevice that is devoid of a medicament and/or that can simulate the useof a corresponding actual medicament delivery device).

The adapter 1210 can be a housing, cover, case, and/or any othersuitable device operable to be coupled to, receive, and/or detect themedicament delivery device. The adapter 1210 can be any of the covers,housings, kits and/or containers described in further detail herein. Theadapter 1210 includes an electronic circuit system coupled thereto. Inparticular, the adapter 1210 includes a processor 1216, a memory 1218, asensor 1214, and a radio 1212. The adapter also includes a communicationmodule 1220, a use (or history) module 1222 and a leash module 1224.Although shown as including each of the communication module 1220, theuse (or history) module 1222 and the leash module 1224, in otherembodiments an adapter need not include all (or any) of these modules.For example, in some embodiments, an adapter includes only a leashmodule 1224, and is configured to perform the leash method associatedtherewith, and need not include the use module 122 or the communicationmodule 1220. Alternatively, in other embodiments an adapter includesonly the communication module 1220.

The processor 1216, and any of the processors described herein, can beany suitable processor for performing the methods described herein. Insome embodiments, processor 1216 can be configured to run and/or executeapplication modules, processes and/or functions associated with such amedicament delivery system 1000. For example, the processor 1216 can beconfigured to run and/or execute the communication module 1220, the use(or history) module 1222 and/or the leash module 1224, and perform themethods associated therewith. The processor 1216 can be, for example, ageneral purpose processor, a Field Programmable Gate Array (FPGA), anApplication Specific Integrated Circuit (ASIC), a Digital SignalProcessor (DSP), and/or the like. The processor 1216 can be configuredto retrieve data from and/or write data to memory, e.g., the memory1218. As described herein, in some embodiments, the processor 1216 cancooperatively function with the radio 1212 and/or execute instructionsfrom code to provide signals to communicatively couple the adapter 1210to the computing device 1510 (e.g., via wireless communication) and/orany other computing entity via a network 1190. In some embodiments, theprocessor 1216 is a Bluetooth® low energy (BLE) processor, such as TheTexas Instruments® CC2540 series of processors, the Broadcom® BCM43341processor, and/or any other processor suitable or configuredspecifically to execute the Bluetooth® v4.0 low energy stack. Aschematic of a Bluetooth® processor is shown in FIG. 2.

In some embodiments, the processor 1216 can be operable to facilitateany suitable communication mode with the computing device 1510 and/orany other computing entity (e.g., by executing the communication module1220). Such modes can include, for example, an active mode, hold mode,sniff mode, and/or park mode in accordance with the Bluetooth® wirelessprotocol. Moreover, the processor 1216 can also be operable to engage inany suitable type of data transfer, such as asynchronous connection-lesslogical transport (ACL), synchronous connection-oriented link (SCO),and/or any other suitable means.

The memory 1218 can be, for example, random access memory (RAM), memorybuffers, hard drives, databases, erasable programmable read only memory(EPROMs), electrically erasable programmable read only memory (EEPROMs),read only memory (ROM), flash memory, hard disks, floppy disks, cloudstorage, and/or so forth. In some embodiments, the memory 1218 storesinstructions to cause the processor 1216 to execute modules, processesand/or functions associated with such medicament delivery system 1000.For example, the memory 1218 can store instructions to cause theprocessor 1216 to execute one or more of the communication module 1220,the use module 1222 and/or the leash module 1224, and perform themethods associated therewith.

The sensor 1214 can be a switch, an audible input sensor (e.g., amicrophone), optical sensor, and/or any other suitable input device. Insome embodiments, the sensor 1214 can be operable to monitor and/ormeasure the configuration and/or status of the medicament deliverydevice 1100. The sensor 1214 can be operable to detect if the medicamentdelivery device 1100 is removed from the adapter 1210, if the medicamentdelivery device 1100 is actuated, and so forth. For example, the sensor1214 can include an electrical contact or switch operable to detect(e.g., in conjunction with the processor 1216) when the medicamentdelivery device 1100 is physically separated from the adapter 1210. Asanother example, the sensor 1214 can include a microphone operable todetect (e.g., in conjunction with the processor 1216) a mechanicaland/or electronic sound associated with the actuation of the medicamentdelivery device, such as a characteristic hiss of a compressed gascontainer being discharged and/or a sound emitted from a speaker of themedicament delivery device 1100 (not shown). As yet another example, thesensor 1214 can include an optical sensor operable to detect theconfiguration of a status window of the medicament delivery device 1100.For example, the sensor 1214 can be operable to detect when a statuswindow of the medicament delivery device 1100 turns color or opaque,which may be associated with use of the medicament delivery device 1100.

The radio 1212 (also referred to as a receiver, transmitter and/ortransceiver) can be operable to send signals to, and/or receive radiosignals, such as Bluetooth®, ZigBee, WiFi, cellular telephone signals,etc. In some embodiments, such as embodiments where the processor 1216is Bluetooth® processor, the radio 1212 can be integral with theprocessor 1216. In other embodiments, the radio 1212 can include aprocessor distinct from the processor 1216. In some embodiments, theradio 1212 can be operable to communicatively couple (also referred toherein as “linking” or “pairing”) the adapter 1210 to the computingdevice 1510 and/or any other computing entity via a network 1190. Theradio 1212 can include or be coupled to a ceramic chip antenna, astamped antenna, a sintered antenna, a PCB conductive trace antenna,and/or any other suitable antenna.

The communication module 1220 can be a hardware and/or software module(stored in memory 1218 and/or executed in the processor 1216). Asdescribed in more detail herein, the communication module 1220 isconfigured to receive an indication (e.g., from the sensor 1214) and/ortransition information associated with a change in status of themedicament delivery device 1100 and determine, based on the indicationor the transition information, a connection and/or communicationscharacteristic. Such communication characteristics can include, forexample, a communication interval and/or connection interval (e.g., atime period between successive signals or portions of a signal, such an“advertising interval,” also referred to herein as a “connectioninterval”), a communication mode (e.g., a park mode, sniff mode or thelike), etc.

The use module 1222 can be a hardware and/or software module (stored inmemory 1218 and/or executed in the processor 1216). As described in moredetail herein, the use module 1222 is configured to receive anindication (e.g., from the sensor 1214) and/or use informationassociated with a use or history of the medicament delivery device 1100and produce a script (e.g., a recorded speech instruction) basedthereupon. In this manner, the use module 1222 can facilitate theadapter 1210 and/or the medicament delivery device 1100 (or simulatedmedicament delivery device) being a “smart” device that can produceupdated instructions and/or guidance based on the past history of usage.

The leash module 1224 can be a hardware and/or software module (storedin memory 1218 and/or executed in the processor 1216). As described inmore detail herein, the leash module 1224 is configured to receiveinformation associated with the connection (or pairing) between theadapter 1210 and the computing device 1510 and produce an alarm basedthereupon. In some embodiments, the leash module 1224 can base thealarms on the position and/or location of the adapter 1210 and/or thecomputing device 1510.

The network 1190 can be a piconet, the Internet, an intranet, a localarea network (LAN), a wide area network (WAN), a virtual network, atelecommunications network, any other suitable communication systemand/or combination of such networks. The network 1190 can be implementedas a wired and/or wireless network.

The computing device 1510 can a mobile computing entity, such as a smartmobile phone (e.g., an iPhone®, an Android® device, a Windows® phone, aBlackberry® phone, etc.), a tablet computer (e.g., an Apple iPad®, aSamsung Nexus® device, a Microsoft Surface® device, etc.), and/or anyother suitable computing entity. The computing device 1510 includes aprocessor 1516, a memory 1518, and a radio 1512.

The processor 1516 can be, for example, a general purpose processor, aFPGA, an ASIC, a DSP, and/or the like. The processor 1516 can beconfigured to retrieve data from and/or write data to memory, e.g., thememory 1518, which can be, for example, RAM, memory buffers, harddrives, databases, EPROMs, EEPROMs, ROM, flash memory, hard disks,floppy disks, cloud storage, and/or so forth.

The radio 1512 can be structurally and/or functionally similar to theradio 1212. In some embodiments, the radio 1512 can include a processor(e.g., a Bluetooth® processor) distinct from the processor 1516. In someembodiments, a short-range radio link can be established between thecomputing device 1510 and the adapter 1210. For example, the computingdevice 1510 and the adapter 1210 can be paired via the Bluetooth®wireless protocol. In such an embodiment, as described in further detailherein, the computing device 1510 can be operable to send and/or receivedata from the adapter 1210 related to the medicament delivery device1100, such as data associated with use, preparation for use, status, andso forth. Furthermore, the adapter 1210 and/or the computing device 1510can be operable to determine when a short-range communication link isbroken (e.g., when the adapter 1210 is out of range of the computingdevice 1510).

The leash module 1524 can be a hardware and/or software module (storedin memory 1518 and/or executed in the processor 1516). As described inmore detail herein, the leash module 1524 is configured to receiveinformation associated with the connection (or pairing) between theadapter 1210 and the computing device 1510 and produce an alarm basedthereupon. In some embodiments, the leash module 1524 can base thealarms on the position and/or location of the adapter 1210 and/or thecomputing device 1510.

In some embodiments, such as an embodiment where the computing device1510 is a Bluetooth® enabled mobile phone, the radio 1512 can besuitable to establish a short-range radio link with the adapter 1210 andestablish a long-range with another computing device (e.g., the remotedevice 1610) via the network. For example, the radio 1512 can be adual-function radio and/or the computing device 1510 can includemultiple radios to relay information associated with the adapter 1210(which may be equipped with only a short-range radio) to the remotedevice 1610 using, for example, a cellular data network and/or a WiFilink to the Internet. In other embodiments, the adapter 1210 may beequipped with a radio operable to communicate with the remote device1610 via the network 1190.

The computing device 1510 can be operable to store (e.g., in the memory1218) information associated with the adapter 1210, such as connectiontime, medicament device 1100 use record, and so forth. In someembodiments, the computing device 1510 can be operable to determine itslocation (e.g., via a global positioning system (GPS) sensor (notshown)). In such an embodiment, the computing device 1510 can beoperable to associate location data with information associated with theadapter 1210, such as use data.

The remote device 1610 can be any suitable computing entity, such as aserver or personal computer. The remote device 1616 includes a processor1616, which can be, for example, a general purpose processor, a FPGA, anASIC, a DSP, and/or the like. The processor 1616 can be configured toretrieve data from and/or write data to memory, e.g., the memory 1618,which can be, for example, RAM, memory buffers, hard drives, databases,EPROMs, EEPROMs, ROM, flash memory, hard disks, floppy disks, cloudstorage, and/or so forth. The network module 1612 can be any suitablemodule operable to communicatively couple the remote device 1610 to thenetwork 1190. For example, the network module 1612 can be a networkinterface controller (NIC).

In some embodiments, the remote device 1610 can be operable to receivereports associated with the medicament delivery device 1100 from theadapter 1210 and/or the computing device 1510 via the network 1190. Forexample, the remote device 1610 can be associated with a healthcareprovider and/or emergency contact and used to monitor medicamentdelivery device 1100 use and/or compliance.

In some embodiments, the processor 1216 of the adapter 1210 and/or theprocessor 1516 of the computing device 1510 (and any of the processorsdescribed herein) can be operable to execute code to implement awireless communications protocol. For example, the processor 1216 and/orthe processor 1516 can execute a Bluetooth® stack (which may be storedin memory 1218, 1518) having service, profile, and/or application layersoperable to control and/or improve connectivity, power management,and/or any other suitable feature associated with the Bluetooth®protocol. For example, as described in further detail herein, theprocessor(s) 1216, 1516, can be operable to alter mode (e.g., from parkto sniff, from sniff to active, or any other suitable change), altercommunication type (e.g., from ACL communication to SCO communication),alter advertising interval, and/or any other suitable communicationparameter. In this manner, in accordance with the methods describedherein, the processor 1216 and/or the processor 1516 can alter and/orimplement a characteristic of the wireless communication in response toa change associated with the medicament delivery device 1100 (orsimulated medicament delivery device). As one example, the processor(s)1216, 1516 can be operable to alter a communication mode fromadvertising a connectable status on a first channel (or set of channels)to sending and/or receiving communication packets on a second channel(or set of channels).

As described in further detail herein, in some embodiments, thecomputing device 1510 can be operable to track the location and/orstatus of the adapter 1210. For example, by recording when the computingdevice 1510 is communicatively coupled to the adapter 1210, which may beassociated with location information, the computing device 1510 canprovide an indication of the last location at which it was linked to theadapter 1210. Furthermore, the computing device 1510 can be operable touse triangulation, homing, and/or any other suitable technique to locatethe adapter 1210 when the adapter 1210 is within radio range. Inaddition or alternatively, the computing device 1510 can send a signalto the adapter 1210 operable to cause the adapter to emit a noise orother signal to aid the user in locating the adapter 1210 (and themedicament delivery device 1000).

In some embodiments, as described in further detail herein, thecomputing device 1510 and/or the adapter 1210 can include a leashfunctionality (e.g., implemented in the leash module 1224 and/or theleash module 1524) such that when the communications between thecomputing device 1510 and the adapter 1210 is disrupted (e.g., thecommunication device 1510 moves out of range and/or vice versa), theadapter 1210 and/or the communication device 1510 can generate an alertto notify a user that a link has been lost. For example, an individualmay be advised to carry a medicament delivery device, such as anepinephrine auto-injector, but may rarely use the medicament deliverydevice. As a result, the user may occasionally forget to carry themedicament delivery device, which can have serious consequences in theevent of a medical emergency. If the user additionally carries thecomputing device 1510, and is less likely to forget the computing device1510 (for example, where the computing device 1510 is a mobile phonethat the user uses on a regular basis), a leash function can alert theuser if the medicament delivery device 1100 is forgotten. In someembodiments, the computing device 1510 and/or the adapter 1210 cangenerate an alert any time the computing device 1510 is moved out ofrange of the adapter 1210 (i.e., indicating that the adapter 1210 is notbeing carried together with the computing device 1510). In anotherembodiment, the computing device 1510 can be operable to verify itslocation (e.g. via GPS) and alert if the computing device 1510 is out ofrange of the adapter 1210 and the computing device 1510 has moved adistance from the position where it was last coupled to the adapter1210. Such an embodiment can reduce false alarms, which may be caused byradio interference, traveling only a short distance from the medicamentdelivery device 1100, and so forth. For example, the computing device1510 can be configured to produce an alert when it loses connectivitywith the medicament delivery device 1100 and is more than ⅛ of a milefrom the last location at which the computing device 1510 was linked tothe adapter 1210. Any other suitable threshold, such as 200 feet, ½mile, 5 miles, etc. is possible. In addition or alternatively, an alertcan be generated if the communication link is lost and the computingdevice 1510 is moving at more than a threshold velocity, such as 10 mph,20 mph, 50 mph, etc. which may be associated with traveling byautomobile. In this manner, the leash feature may reduce false alarmsthat can occur where the user is within walking distance of themedicament delivery device 1100 (e.g., the user may be walking within alarge building and the communications between the computing device 1510and the adapter 1410 may be temporarily disrupted.

In some embodiments, as described in further detail herein, thecomputing device 1510 and/or the adapter 1210 can include a statustracking functionality such that when the medicament delivery device1100 (and/or a simulated medicament delivery device 1100) changesstatus, the adapter 1210 can adjust the communications protocol and/orcharacteristics. For example, in some embodiments, the adapter 1210 canenhance the electronic communications with the computing device 1510 bychanging a signaling rate, signal power and/or the information containedin a signal sent via the radio 1212 in response to the actuation of themedicament delivery device 1100 (and/or a simulated medicament deliverydevice 1100).

In some embodiments, for example, the adapter 1210 can be operable toswitch between several connection and/or communication modes (each ofwhich may be associated with different broadcast intervals, powerconsumption levels or the like). For example, the adapter 1210 can havean off mode, where there is substantially no electrical activity (e.g.,no power draw) associated with the processor 1216 and/or the radio 1212.When the adapter 1210 is in the off mode, there is no communicationsbetween the adapter 1210 and the computing device 1510 and/or the remotedevice 1610. In some embodiments, an electrical connection between apower source (e.g., a battery) and the processor 1216 and/or the radio1212 may be mechanically isolated when the adapter 1210 is in the offmode. In other embodiments, the power source can remain electricallycoupled to the processor 1216 and/or the radio 1212, but communicationsactivity can be otherwise curtailed to limit power consumption.

As another example, the adapter 1210 can be operable in a connectablemode where the adapter 1210 is available to link with and/or issoliciting a link with the computing device 1510. For example, when inthe connectable mode, the adapter 1210 can repeatedly send a signal toadvertise its availability to establish a communication link (or “pairwith”) the computing device 1510 via the radio 1212. In someembodiments, the advertising signal can be sent in a non-periodicadvertising interval, which can avoid synchronization with the computingdevice 1510 (e.g., avoid the adapter 1210 advertising on a cycle thatdoes not overlap with a computing device 1510 “listening” cycle). Insome embodiments, the advertising interval can be based, at least inpart, on the status of the medicament delivery device 1100. In thismanner, the adapter 1210 can control the electronic communications withthe computing device 1510 to limit the power consumption during periodswhen such communications are less likely. For example, if the medicamentdelivery device 1100 is disposed within the adapter 1210 a relativelylong advertising interval (such as about 7 ms, about 10 ms, about 20 ms,about 152.5 ms, about 211.25 ms, about 500 ms, about 760 ms, about 1 s,about 5 s, 5 min, and/or any other suitable interval therebetween) canbe chosen. If, on the other hand, the medicament delivery device 1100has been removed from the adapter 1210, a relatively short advertisinginterval (such as about 1 ms, about 3, ms, about 10 ms, about 20 msand/or any other suitable interval) can be chosen and/or power can beincreased to the radio 1212. In this way, the adapter 1210 can conservepower when the medicament delivery device 1100 is not configured todeliver a medicament, while prioritizing connectivity and/or reducinglatency when the medicament delivery device 1100 is poised to deliver amedicament.

As another example, the adapter 1210 can have a connected mode, forexample, where the adapter 1210 is linked with the computing device 1510(i.e., the adapter 1210 and the computing device 1510 form a piconet).When the adapter 1210 is in the connected mode, the adapter 1210 canperiodically exchange messages with the computing device 1510 tomaintain the connection. In some embodiments, the communication interval(i.e., the time interval between successive signals and/or portions of asignal, also referred to herein as a “connection interval”) can beselected in accordance with a status of the adapter 1210 and/ormedicament delivery device 1100 to minimize power consumption. Forexample, the communication interval can be 0.5 s, 1 s, 2 s, and/or anyother suitable interval. In some embodiments, the adapter 1210 canselectively enter a particular “mode” of communications when connectedwith the computing device 1510. For example, the Bluetooth® Low Energyprotocol employs a sleep mode, a sniff mode and park mode to facilitateconservation of power of the slave device (i.e., the adapter 1210, inthis example). In some embodiments, the adapter 1210 can selectivelyenter the sleep, sniff, and/or park mode once connected, in response toa change in status of the medicament delivery device 1100 (e.g.,removed, armed, actuated) and/or if the data associated with themedicament delivery device 1100 is not transferred for a period of time.

In some embodiments, for example, the adapter 1210 can be configuredsuch that the radio 1212 is configured to send a first signalcharacterized by a first communication interval and/or mode when themedicament delivery device 1100 is in a first configuration. The firstsignal can be, for example, an advertising signal characterized by afirst advertising interval. In other embodiments, the first signal canbe a signal to maintain an already-exiting pairing between the adapter1210 and the computing device 1510. The first configuration of themedicament delivery device 1100 can be, for example, a “standby”configuration (when the device is within and/or coupled to the adapter1210). Alternatively, the first configuration can be any other suitableconfiguration (e.g., an armed configuration, a “power off” configurationor the like). The radio is configured to send a second signalcharacterized by a second communication interval and/or mode when themedicament delivery device is in a second configuration. The secondcommunication interval can be different from the first communicationinterval.

In some embodiments, the computing device 1510 can send a signal to theadapter 1210 to cause the adapter to emit an audible output. In someembodiments, there may be limited space in the memory 1218 of theadapter 1210 to store voice prompts and/or customized voice prompts,and/or the memory 1218 may be ROM memory or another type of memory thatis not writeable and/or requires significant time, computationalresources, and/or power to alter. In such an embodiment, sending asignal from the computing device 1510, which may have more memory and/orcomputational power, to cause the adapter 1210 to generate an output,can extend the battery life of the adapter 1210 and/or can allow theadapter 1210 to be more flexible and/or customizable than the processor1216, the memory 1218. Such methods can further address the powerconstraints of the adapter 1210 by using less power than if the outputwere generated entirely by the adapter 1210.

In other embodiments, the electronic configuration of the adapter 1210can facilitate methods of updating an instruction script and/or voiceprompt stored in the memory 1218 of the adapter 1210. For example, insome embodiments, the adapter 1210 can receive signals from thecomputing device 1510 via the radio 1212 that include informationassociated with an instruction script and/or voice prompt of the typesdescribed herein. This information can then be written to the memory1218, thus allowing the voice prompts to be updated using the wirelesscommunications capabilities described herein. These methods avoid theneed to have the voice prompts contained in a ROM mask, which can bedifficult to update. Moreover, these methods allow for the user tocustomize their voice prompts (e.g., with a specific user's voice, withcustomized content or the like).

In some embodiments, the adapter 1210 can be associated with a uniqueidentifier and/or part number. In such an embodiment, when the computingdevice 1510 pairs with the adapter 1210 the computing device 1510 (e.g.,by communicating with the remote device 1610, which may include adatabase of adapters 1210) can retrieve information associated with themedicament delivery device 1100, such as type of medicament, expirationdate, particular use instructions, and so forth.

Although described as facilitating a user-implemented update to a voiceprompt, in other embodiments, the adapter 1210 (and any of the systemdescribed herein) can be configured to update the voice prompts based onthe user's past history (e.g., via the use module 1222). In this manner,the systems and methods described herein can be used to produce a“smart” or “trainable” device. In some embodiments, the medicamentdelivery device 1100 can be a simulated medicament delivery deviceintended for use training a user in the operation of an actualmedicament delivery device. In such an embodiment, the adapter 1210(and/or the simulated medicament delivery device 1100 itself) can beoperable to detect whether the simulated medicament delivery device wasused properly. For example, via input received from the sensor 1214(and/or a series of sensors), the adapter 1210 can be operable to detectwhether the simulated medicament delivery device was properly armed,whether it was properly positioned to simulate delivery of medicament,whether sufficient force was applied to actuate the simulated medicamentdelivery device, whether the medicament delivery device was held inposition for a sufficient period of time, and so forth. The adapter 1210can send a signal to the computing device 1510 such that personalizedinstructions can be provided to the user by the computing device 1510and/or the adapter 1210. For example, if the user applies insufficientforce to actuate the simulated medicament delivery device, thisinformation can be stored within the memory 1218 and the adapter 1210,the simulated device 1100, and/or the computing device 1510 can beoperable to instruct the user to apply additional force and/or to remindthe user that insufficient force was applied in previous instances.Furthermore, in some embodiments, a record of simulated medicamentdelivery device use can be stored by the adapter 1210, the computingdevice 1510, and/or the remote device 1610, such that personalizedinstructions in the event the user attempts to use an actual medicamentdelivery device 1100. For example, the computing device 1510 can remindthe user of mistakes made with a simulated medicament delivery device,for example, to remind the user that he or she has a history of applyinginsufficient force when practicing with the simulated medicamentdelivery device. Similarly stated, the computing device and/or theremote device 1610 can be operable to provide information to the user ofthe medicament delivery device 1100 based on data associated with asimulated medicament delivery device.

In some embodiments, an application (executing on the processor 1516 ofthe computing device 1510) can be operable to detect and/or pair withmultiple adapters. For example, the communication device 1510 can beoperable to detect one or more adapters (coupled to medicament deliverydevices) at a retail location, such as a pharmacy. In such anembodiment, the computing device 1510 can send a signal to and/orreceive a signal from the remote device 1610 indicating the location ofthe adapters. The remote device 1610, in turn can provide information tousers (e.g., via the Internet) of the location of the adapters. Thus,the remote device 1610 can be operable to provide, for example, to auser, sales rep, healthcare professional, etc. information about theavailability of a particular medicament delivery device or particulartype of medicament delivery device. Furthermore, in the event of amedicament recall or expiration, the remote device 1610 can have adatabase of locations having the recalled or expired medicament.

The methods and systems described herein can be used in conjunction withany suitable medicament delivery device. For example, FIGS. 3-34 show amedical injector 4000 as another example of a delivery device that canbe used in conjunction with and/or as a part of the delivery systems andmethods described herein. FIGS. 3-4 are perspective views of the medicalinjector 4000 in a first configuration (i.e., prior to use). The medicalinjector 4000 includes a housing 4110, a delivery mechanism 4500 (seee.g., FIG. 12), an electronic circuit system 4900 (see e.g., FIGS.13-23), a cover 4200 (see e.g., FIGS. 24-25), a safety lock 4700 (seee.g., FIGS. 26-29) and a base 4300 (see e.g., FIGS. 30-31). A discussionof the components of the medical injector 4000 will be followed by adiscussion of the operation of the medical injector 4000.

As shown in FIGS. 5-11, the housing 4110 has a proximal end portion 4140and a distal end portion 4120. The housing 4110 defines a first statusindicator aperture 4150 and a second status indicator aperture 4151. Thefirst status indicator aperture 4150 defined by the housing 4110 islocated on a first side of the housing 4110, and the second statusindicator aperture 4151 of the housing 4110 is located on a second sideof the housing 4110. The status indicator apertures 4150, 4151 can allowa patient to monitor the status and/or contents of a medicamentcontainer 4560. For example, by visually inspecting the status indicatorapertures 4150, 4151, a patient can determine whether the medicamentcontainer 4560 contains a medicament and/or whether a medicament hasbeen dispensed.

As shown in FIGS. 9 and 10, the housing 4110 defines a gas cavity 4154,a medicament cavity 4157 and an electronic circuit system cavity 4153.The gas cavity 4154 has a proximal end portion 4155 and a distal endportion 4156. The gas cavity 4154 is configured to receive the gascontainer 4570 and the release member 4540 of the medicament deliverymechanism 4500 (see e.g., FIG. 12) as described in further detailherein. The proximal end portion 4155 of the gas cavity 4154 isconfigured to receive the gas container retention member 4580 of theproximal cap 4112 of the housing 4110, as described in further detailherein. The gas cavity 4154 is in fluid communication with themedicament cavity 4157 via a gas passageway 4144, as described infurther detail herein, and the gas cavity 4154 is in fluid communicationwith a region outside the housing 4110 via a safety lock aperture 4128.

The medicament cavity 4157 is configured to receive a portion of thedelivery mechanism 4500. In particular, the carrier 4520, the moveablemember 4530 and the needle 4512 of the medicament delivery mechanism4500 are movably disposed in the medicament cavity 4157. The medicamentcavity 4157 is in fluid communication with a region outside the housing4110 via a needle aperture 4122.

The electronic circuit system cavity 4153 is configured to receive theelectronic circuit system 4900. The housing 4110 has protrusions 4149(see e.g., FIG. 8) configured to stabilize the electronic circuit system4900 when the electronic circuit system 4900 is disposed within theelectronic circuit system cavity 4153. The housing 4110 also definesconnection apertures 4152 configured to receive connection protrusions4171 of the electronic circuit system 4900, and aperture 4145 (see e.g.,FIG. 6) configured to receive a portion of a protrusion 4174 of theelectronic circuit system 4900. In this manner, the electronic circuitsystem 4900 can be coupled to the housing 4110 within the electroniccircuit system cavity 4153. In other embodiments, the electronic circuitsystem 4900 can be coupled within the electronic circuit system cavity4153 by other suitable means such as an adhesive, a clip and/or thelike.

The electronic circuit system cavity 4153 is fluidically and/orphysically isolated from the gas cavity 4154 and/or the medicamentcavity 4157 by a sidewall 4148. The sidewall 4148 can be any suitablestructure to isolate the electronic circuit system cavity 4153 withinthe housing 4110 from the gas cavity 4154 and/or the medicament cavity4157 within the housing 4110. Similarly, the gas cavity 4154 and themedicament cavity 4157 are separated by a sidewall 4146. In someembodiments, sidewall 4146 can be similar to the sidewall 4148, whichisolates the gas cavity 4154 and the medicament cavity 4157 from theelectronic circuit system cavity 4153. In other embodiments the gascavity 4154 can be fluidically and/or physically isolated from themedicament cavity 4157.

The proximal end portion 4140 of the housing 4110 includes a proximalcap 4112, a speaker protrusion 4147 (see e.g., FIGS. 8 and 9), and coverretention protrusions 4142 (see e.g., FIGS. 4 and 6). The speakerprotrusion 4147 is configured to maintain a position of an audio outputdevice 4956 of the electronic circuit system 4900 relative to thehousing 4110 when the electronic circuit system 4900 is attached to thehousing 4110, as described herein. Cover retention protrusions 4142 areconfigured to be received within corresponding openings 4215 on thecover 4200. In this manner, as described in more detail herein, thecover 4200 can be removably coupled to and disposed about at least aportion of the housing 4110.

As shown in FIG. 11, the proximal cap 4112 includes a gas containerretention member 4580 and defines a gas passageway 4144. The gascontainer retention member 4580 is configured to receive and/or retain agas container 4570 that can contain a pressurized gas. The gaspassageway 4144 is configured to allow for the passage of gas containedin the gas container 4570 from the gas cavity 4154 to the medicamentcavity 4157, as further described herein. Said another way, the gaspassageway 4144 places the gas cavity 4154 in fluid communication withthe medicament cavity 4157.

As shown in FIGS. 7 and 9, the distal end portion 4120 of the housing4110 defines a battery isolation protrusion aperture 4121, a needleaperture 4122, a safety lock actuator groove 4123, a safety lockaperture 4128, a base actuator groove 4124, base retention recesses4125A, 4125B, and base rail grooves 4127. The battery isolationprotrusion aperture 4121 is configured to receive the battery isolationprotrusion 4235 of the cover 4200 (see e.g., FIG. 25), as described infurther detail herein.

The needle aperture 4122 is configured to allow the needle 4512 (seee.g., FIG. 12) to exit the housing 4110 when the medical injector 4000is actuated. The portion of the sidewall of the housing 4110 thatdefines the needle aperture 4122 includes multiple sheath retentionprotrusions 4126. In some embodiments, the sheath retention protrusionscan interact with the a plurality of ribs 4728 of the needle sheath 4720(see e.g. FIG. 29) to maintain a position of the needle sheath 4720relative to the safety lock 4700 when the safety lock 4700 is coupled tothe housing 4110 and/or when the safety lock 4700 is being removed fromthe housing 4110.

The safety lock actuator groove 4123 is configured to receive anactuator 4744 of the safety lock 4700. As described in more detailherein, the actuator 4744 is configured to engage and/or activate theelectronic circuit system 4900 when the safety lock 4700 is moved withrespect to the housing 4110. The safety lock aperture 4128 is configuredto receive a safety lock protrusion 4742 (see e.g., FIGS. 25 and 26). Asdescribed in more detail below, the safety lock protrusion 4742 isreceived within an opening 4554 between extensions 4552 of a releasemember 4540 such that activation of the medical injector 4000 isprevented when the safety lock 4700 is in place. The safety lock 4700,its components and functions are further described herein.

The distal base retention recesses 4125A are configured to receive thebase connection knobs 4358 of the base 4300 (see e.g., FIG. 30) when thebase 4300 is in a first position relative to the housing 4110. Theproximal base retention recesses 4125B are configured to receive thebase connection knobs 4358 of the base 4300 when the base 4300 is in asecond position relative to the housing 4110. The base retentionrecesses 4125A, 4125B have a tapered proximal sidewall and a non-tapereddistal sidewall. This allows the base retention recesses 4125A, 4125B toreceive the base connection knobs 4358 such that the base 4300 can moveproximally relative to the housing 4110, but cannot move distallyrelative to the housing 4110. Said another way, the distal baseretention recesses 4125A are configured to prevent the base 4300 frommoving distally when the base 4300 is in a first position and theproximal base retention recesses 4125B are configured to prevent thebase 4300 from moving distally when the base 4300 is in a secondposition. Similarly stated, the proximal base retention recesses 4125Band the base connection knobs 4358 cooperatively prevent “kickback”after the medical injector 4000 is actuated.

The base actuator groove 4124 is configured to receive an actuator 4311of the base 4300. As described in more detail herein, the actuator 4311of the base 4300 is configured to engage the electronic circuit system4900 when the base 4100 is moved with respect to the housing 4110. Thebase rail grooves 4127 are configured to receive the guide members 4312of the base 4300. The guide members 4312 of the base 4300 and the baserail grooves 4127 of the housing 4110 engage each other in a way thatallows the guide members 4312 of the base 4300 to slide in a proximaland/or distal direction within the base rail grooves 4127 while limitinglateral movement of the guide members 4312. This arrangement allows thebase 4300 to move in a proximal and/or distal direction with respect tothe housing 4110 but prevents the base 4300 from moving in a lateraldirection with respect to the housing 4110.

FIG. 12 shows the medicament delivery mechanism 4500 of the medicalinjector 4000. The medical injector 4000 is similar to theauto-injectors described in U.S. patent application Ser. No. 11/562,061,entitled “Devices, Systems and Methods for Medicament Delivery,” filedNov. 21, 2006, which is incorporated herein by reference in itsentirety. Accordingly, only an overview of the medicament deliverymechanism 4500 and related operation of the medical injector 4000 isincluded below.

The medicament delivery mechanism 4500 includes a needle 4512, a carrier4520, a movable member 4530, a medicament container 4560, a gascontainer 4570, and a release member 4540. As described above, theneedle 4512, carrier 4520, movable member 4530 and medicament container4560 are disposed within the medicament cavity 4157 of the housing 4110.The gas container 4570 and the release member 4540 are disposed withinthe gas cavity 4154 of the housing 4110.

The release member 4540 has a proximal end portion 4542 and a distal endportion 4544, and is movably disposed within the distal end portion 4156of the gas cavity 4154. The proximal end portion 4542 of the releasemember 4540 includes a sealing member 4545 and a puncturer 4541. Thesealing member 4545 is configured to engage the sidewall of the housing4110 defining the gas cavity 4154 such that the proximal end portion4155 of the gas cavity 4154 is fluidically isolated from the distal endportion 4156 of the gas cavity 4154. In this manner, when gas isreleased from the gas container 4570, the gas contained in the proximalend portion 4155 of the gas cavity 4154 is unable to enter the distalend portion 4156 of the gas cavity 4154. The puncturer 4541 of theproximal end portion 4542 of the release member 4540 is configured tocontact and puncture a frangible seal 4573 on the gas container 4570when the release member 4540 moves proximally within the gas cavity4154, as shown by the arrow BB in FIG. 12.

The distal end portion 4544 of the release member 4540 includesextensions 4552. The extensions 4552 include projections 4547 thatinclude tapered surfaces 4549 and engagement surfaces 4548. Further, theextensions 4552 define an opening 4554 between the extensions 4552. Thetapered surfaces 4549 of the projections 4547 are configured to contactprotrusions 4313 on a proximal surface 4310 of the base 4300 (see e.g.,FIG. 30). The engagement surfaces 4548 of the projections 4547 areconfigured to extend through the safety lock aperture 4128 of thehousing 4110 and contact a distal surface of the housing 4110. In thismanner, the engagement surfaces 4548 of the projections 4547 limitproximal movement of the release member 4540 when the engagementsurfaces 4548 are in contact with the distal surface of the housing4110.

The opening 4554 defined by the extensions 4552 is configured to receivethe safety lock protrusion 4742 of the safety lock 4700 (see e.g., FIG.27). The safety lock protrusion 4742 is configured to prevent theextensions 4552 from moving closer to each other. Said another way, thesafety lock protrusion 4742 is configured to ensure that the extensions4552 remain apart and the engagement surfaces 4548 of the projections4547 remain in contact with the distal end portion 4120 of the housing4110. In some embodiments, for example, the release member 4540 and/orthe extensions 4552 can be constructed from any suitable materialconfigured to withstand deformation that may occur when exposed to aload over an extended period of time. In some embodiments, for example,the release member 4540 and/or the extensions 4552 can be constructedfrom brass.

The gas container 4570 includes a distal end portion 4572 and a proximalend portion 4576, and is configured to contain a pressurized gas. Thedistal end portion 4572 of the gas container 4570 contains a frangibleseal 4573 configured to break when the puncturer 4541 of the proximalend portion 4542 of the release member 4540 contacts the frangible seal4573. The gas container retention member 4580 of the proximal cap 4112of the housing 4110 is configured to receive and/or retain the proximalend portion 4576 of the gas container 4570. Said another way, theposition of the gas container 4570 within the gas cavity 4154 ismaintained by the gas container retention member 4580.

The medicament container 4560 of the medicament delivery mechanism 4500has a distal end portion 4562 and a proximal end portion 4566, and isconfigured to contain a medicament. The distal end portion 4562 of themedicament container 4560 contains a seal 4523. The seal 4523 isconfigured to burst when punctured by the proximal end 4516 of theneedle 4512, as described below. The proximal end portion 4566 of themedicament container 4560 is configured to receive a piston portion 4534of the movable member 4530.

The movable member 4530 of the medicament delivery mechanism 4500 ismovably disposed within the medicament cavity 4157. The movable member4530 includes a piston portion 4534 having a plunger at the distal endportion of the piston portion 4534. The piston portion 4534 isconfigured to move within the medicament container 4560. In this manner,the piston portion 4534 of the movable member 4530 can apply pressure toa medicament contained in the medicament container 4560. The pistonportion 4534 can be constructed of a resilient, durable, and/or sealingmaterial, such as a rubber.

The carrier 4520 of the medicament delivery mechanism 4500 includes adistal end portion 4522 and a proximal end portion 4526. The medicamentcontainer 4560 is coupled to the carrier 4520 via a “snap-fit”connection (not shown) such that the medicament container 4560 can moverelative to the carrier 4520 between a first configuration and a secondconfiguration during an injection event. In the first configuration, thecarrier 4520 is configured to move within the medicament cavity 4157such that movement of the carrier 4520 within the medicament cavity 4157causes contemporaneous movement of the medicament container 4560 withinthe medicament cavity 4157. The proximal end portion 4516 of the needle4512 is spaced apart from the seal 4523 of the medicament container 4560when the carrier 4520 is in the first configuration. In the secondconfiguration, the medicament container 4560 releases from the“snap-fit” causing the medicament container 4560 to move distally withrespect to the carrier 4520, causing the proximal end portion 4516 ofthe needle 4512 to pierce the seal 4523. In this manner, the needle 4512can be selectively placed in fluid communication with the medicamentcontainer 4560 to define a medicament delivery path (not shown).

FIGS. 13-22 show the electronic circuit system 4900. The electroniccircuit system 4900 of the medical injector 4000 includes an electroniccircuit system housing 4170, a printed circuit board 4922, a batteryassembly 4962, an audio output device 4956, two light emitting diodes(LEDs) 4958A, 4958B and a battery clip 4910. As shown in FIG. 20, theelectronic circuit system 4900 is configured to fit within theelectronic circuit system cavity 4153 of the housing 4110. Accordingly,as described above, the electronic circuit system 4900 is physicallyand/or fluidically isolated from the medicament cavity 4157, the gascavity 4154 and/or the medicament delivery device 4500. As describedherein, the electronic circuit system 4900 is configured to output anelectronic output associated with the use of the medical injector 4000.

The electronic circuit system housing 4170 of the electronic circuitsystem 4900 includes a distal end portion 4180 and a proximal endportion 4190. The proximal end portion 4190 includes connectionprotrusions 4171A and a battery clip protrusion 4173. The connectionprotrusions 4171A extend from the proximal end portion 4190 of theelectronic circuit system housing 4170, and are configured to bedisposed within the connection apertures 4152 of the housing 4110, asdescribed above. In this manner, the electronic circuit system 4900 canbe coupled to the housing 4110 within the electronic circuit systemcavity 4153. In other embodiments, the electronic circuit system 4900can be coupled to the housing 4110 by other suitable means such as anadhesive, a clip and/or the like. As described in more detail herein,the battery clip protrusion 4173 is configured to hold the battery clip4910 in place.

The proximal end portion 4190 of the electronic circuit system housing4170 defines multiple sound apertures 4191. The audible output device4956 is disposed against the proximal end portion 4190 of the electroniccircuit system housing 4170 such that the front face of the audibleoutput device 4956 is disposed adjacent the sound apertures 4191. Inthis manner, the sound apertures 4191 are configured to allow sound froman audio output device 4956 to pass from the audio output device 4956 toa region outside of the housing 4110.

As shown in FIGS. 16 and 17, the distal end portion 4180 of theelectronic circuit system housing 4170 includes a connection protrusion4171B, a stiffening protrusion 4174, and defines an LED aperture 4181,an aperture 4172, a safety lock actuator groove 4182, and a baseactuator groove 4183. The LED aperture 4181 is configured to receive theLEDs 4958A, 4958B such that a user can view the LEDs 4958A, 4958B, whichare described in more detail herein.

The connection protrusion 4171B extends from the distal end portion 4180of the electronic circuit system housing 4170, and is configured toattach the electronic circuit system 4900 to the housing 4110, asdescribed above. The stiffening protrusion 4174 is configured to have atleast a portion received within and/or accessible via the aperture 4145in the housing 4110 (see e.g., FIG. 6). The stiffening protrusion 4174is configured to limit the bending (e.g., buckling) of the electroniccircuit system housing 4170 when the electronic circuit system housing4170 is coupled to the housing 4110. Moreover, a user can access thestiffening protrusion 4174 via the aperture 4172. In this manner, forexample, the user can disengage the stiffening protrusion 4174 from theaperture 4145.

The safety lock actuator groove 4182 of the electronic circuit systemhousing 4170 is configured to be disposed adjacent the safety lockactuator groove 4123 of the distal end portion 4120 of the housing 4110.In this manner, the safety lock actuator groove 4182 of the electroniccircuit system housing 4170 and the safety lock actuator groove 4123 ofthe distal end portion 4120 of the housing 4110 collectively receive theactuator 4744 of the safety lock 4700, which is described in more detailherein. Similarly, the base actuator groove 4183 of the electroniccircuit system housing 4170 is configured to be disposed about the baseactuator groove 4124 of the distal end portion 4120 of the housing 4110.The base actuator groove 4183 of the electronic circuit system housing4170 and the base actuator groove 4124 of the distal end portion 4120 ofthe housing 4110 collectively receive the actuator 4311 of the base4300, which is described in more detail herein.

The printed circuit board 4922 of the electronic circuit system 4900includes a substrate 4924, a first actuation portion 4926 and a secondactuation portion 4946. The substrate 4924 of the printed circuit board4922 includes the electrical components necessary for the electroniccircuit system 4900 to operate as desired. For example, the electricalcomponents can be resistors, capacitors, inductors, switches,microcontrollers, microprocessors and/or the like.

As shown in FIGS. 21-23, the first actuation portion 4926 includes afirst electrical conductor 4934 and defines an opening 4928 having aboundary 4929. The opening 4928 of the first actuation portion 4926 isconfigured to receive a protrusion 4746 of the actuator 4744 of thesafety lock 4700. The boundary 4929 of the first opening 4928 has adiscontinuous shape, such as, for example, a teardrop shape, thatincludes a stress concentration riser 4927. The discontinuity and/or thestress concentration riser 4927 of the boundary 4929 can be of anysuitable shape to cause the substrate 4924 to deform in a predetermineddirection when the protrusion 4746 of the actuator 4744 of the safetylock 4700 is moved relative to the opening 4928, as shown by the arrowCC in FIG. 22.

The opening 4928 is defined adjacent the first electrical conductor 4934that electronically couples the components included in the electroniccircuit system 4900. The first electrical conductor 4934 includes afirst switch 4972, which can be, for example a frangible portion of thefirst electrical conductor 4934. In use, when the safety lock 4700 ismoved from a first position (see e.g., FIG. 21) to a second position(see e.g., FIG. 22), the actuator 4744 moves in a directionsubstantially parallel to a plane defined by a surface of the firstactuation portion 4926 of the substrate 4924. The movement of theactuator 4744 causes the protrusion 4746 to move within the firstopening 4928, as indicated by the arrow CC in FIG. 22. The movement ofthe protrusion 4746 tears the first actuation portion 4926 of thesubstrate 4924, thereby separating the portion of the first electricalconductor 4934 including the first switch 4972. Said another way, whenthe safety lock 4700 is moved from its first position to its secondposition (see e.g., FIG. 33), the actuator 4744 moves irreversibly thefirst switch 4972 from a first state (e.g., a state of electricalcontinuity) to a second state (e.g., a state of electricaldiscontinuity). Said yet another way, when the safety lock 4700 is movedfrom its first position to its second position, the actuator 4744disrupts the first electrical conductor 4934.

The second actuation portion 4946 includes a second electrical conductor4935 and defines an opening 4945, having a boundary 4949 and a tearpropagation limit aperture 4948. As shown in FIGS. 20-23, the opening4945 of the second actuation portion 4946 is configured to receive aportion of an actuator 4311 of the base 4300. The boundary 4949 of theopening 4945 has a discontinuous shape that includes a stressconcentration riser 4947. The discontinuity and/or the stressconcentration riser 4947 of the boundary 4949 can be of any suitableshape to cause the substrate 4924 to deform in a predetermined directionwhen the actuator 4311 of the base 4300 is moved in a proximal directionrelative to the opening 4945, as shown by the arrow DD in FIG. 23.

The second electrical conductor 4935 includes a second switch 4973disposed between the opening 4945 and the tear propagation limitaperture 4948, which can be, for example, a frangible portion of thesecond electrical conductor 4935. In use, when the base 4300 is movedfrom its first position to its second position (see e.g., FIG. 34), theactuator 4311 moves in a proximal direction, substantially parallel to aplane defined by a surface of the second actuation portion 4946 of thesubstrate 4924. The proximal movement of the actuator 4311 tears thesecond actuation portion 4946 of the substrate 4924, thereby separatingthe portion of the second electrical conductor 4935 including the secondswitch 4973. Said another way, when the base 4300 is moved from itsfirst position to its second position, the actuator 4311 movesirreversibly the second switch 4973 from a first state (e.g., a state ofelectrical continuity) to a second state (e.g., a state of electricaldiscontinuity). The tear propagation limit aperture 4948 is configuredto limit the propagation of the tear in the substrate 4924 in theproximal direction. Said another way, the tear propagation limitaperture 4948 is configured to ensure that the tear in the substrate4924 does not extend beyond the tear propagation limit aperture 4948.The tear propagation limit aperture 4948 can be any shape configured tostop the propagation of a tear and/or disruption of the substrate 4924.For example, the tear propagation limit aperture 4948 can be ovalshaped. In other embodiments, the proximal boundary of the tearpropagation limit aperture 4948 can be reinforced to ensure that thetear in the substrate 4924 does not extend beyond the tear propagationlimit aperture 4948.

The battery assembly 4962 of the electronic circuit system 4900comprises two batteries stacked on top of one another. The batteryassembly 4962 has a first surface 4964 and a second surface 4966. Thefirst surface 4964 of the battery assembly 4962 can contact anelectrical contact (not shown) disposed on the substrate 4924. Thesecond surface 4966 of the battery assembly 4962 is configured tocontact a contact portion 4918 of a distal end portion 4916 of a batteryclip 4910. When both the electrical contact of the substrate 4924 andthe contact portion 4918 of the distal end portion 4916 of the batteryclip 4910 contact the battery assembly 4962, the batteries of thebattery assembly 4962 are placed in electrical communication with theelectronic circuit system 4900. Said another way, when the electricalcontact of the substrate 4924 and the contact portion 4918 of the distalend portion 4916 of the battery clip 4910 contact the battery assembly4962, the battery assembly 4962 is configured to supply power to theelectronic circuit system 4900.

The battery clip 4910 (shown in FIG. 18) includes a proximal end portion4912 and a distal end portion 4916. The proximal end portion 4912defines a retention aperture 4913. The retention aperture 4913 isconfigured to receive the battery clip protrusion 4173 of the electroniccircuit system housing 4170. In this manner, the battery clip protrusion4173 maintains the position of the battery clip 4910 with respect to theelectronic circuit system housing 4170 and/or the battery assembly 4962.

The distal end portion 4916 of the battery clip 4910 includes a contactportion 4918 and an angled portion 4917. As described above, the contactportion 4918 is configured to contact the second surface 4916 of thebattery assembly 4962 to place the battery assembly 4962 in electricalcommunication with the electronic circuit system 4900. The angledportion 4917 of the distal end portion 4916 of the battery clip 4910 isconfigured to allow a proximal end portion 4236 of a battery isolationprotrusion 4235 (see e.g., FIG. 25) to be disposed between the secondsurface 4966 of the battery assembly 4962 and the contact portion 4918of the distal end portion 4916 of the battery clip 4910. When thebattery isolation protrusion 4235 is disposed between the second surface4966 of the battery assembly 4962 and the contact portion 4918 of thedistal end portion 4916 of the battery clip 4910, the electrical pathbetween the battery assembly 4962 and the remainder of the electricalcircuit system 4900 is severed, thereby removing power from theelectronic circuit system 4900. The contact portion 4918 of the distalend portion 4916 of the battery clip 4910 is biased such that when thebattery isolation protrusion 4235 is removed, the contact portion 4918will move into contact the second surface 4916 of the battery assembly4962, thereby restoring electrical communication between the batteryassembly 4962 and the electronic circuit system 4900. In someembodiments, the battery isolation protrusion 4235 can be repeatedlyremoved from between the second surface 4966 of the battery assembly4962 and the contact portion 4918 of the distal end portion 4916 of thebattery clip 4910 and reinserted. Said another way, the batteryisolation protrusion 4235 and the battery clip 4910 collectively form areversible on/off switch.

The audio output device 4956 of the electronic circuit system 4900 isconfigured to output audible sound to a user in response to a use of themedical injector 4000. In some embodiments, the audible output device4956 can be a speaker. In some embodiments, the audible sound can be,for example, associated with a recorded message and/or a recordedspeech. In other embodiments, the audible instructions can be an audiblebeep, a series of tones and/or or the like.

In other embodiments, the medical injector 4000 can have a networkinterface device (not shown) configured to operatively connect theelectronic circuit system 4900 to a remote device (not shown) and/or acommunications network (not shown). In this manner, the electroniccircuit system 4900 can send information to and/or receive informationfrom the remote device. The remote device can be, for example, a remotecommunications network, a computer, a compliance monitoring device, acell phone, a personal digital assistant (PDA) or the like. Such anarrangement can be used, for example, to download replacementprocessor-readable code from a central network to the electronic circuitsystem 4900. In some embodiments, for example, the electronic circuitsystem 4900 can download information associated with a medical injector4000, such as an expiration date, a recall notice, updated useinstructions or the like. Similarly, in some embodiments, the electroniccircuit system 4900 can upload compliance information associated withthe use of the medical injector 4000 via the network interface device.

FIGS. 24 and 25 show the cover 4200 of the medical injector 4000. Thecover 4200 includes a proximal end portion 4210 and a distal end portion4230, and defines a cavity 4242. The cavity 4242 of the cover 4200 isconfigured to receive at least a portion of the housing 4110. Theproximal end portion 4210 defines apertures 4215 configured to receivethe cover retention protrusions 4142 of the housing 4110 (shown in FIGS.4 and 6). In this manner, the apertures 4215 and the cover retentionprotrusions 4142 of the housing 4110 removably retain the cover 4200about at least a portion of the housing 4110. Said another way, theapertures 4215 and the cover retention protrusions 4142 of the housing4110 are configured such that the cover 4200 can be removed from aportion of the housing 4110 and then replaced about the portion of thehousing 4110.

The distal end portion 4230 of the cover 4200 includes a batteryisolation protrusion 4235. The battery isolation protrusion 4235includes a proximal end portion 4236 and a tapered portion 4237. Theproximal end portion 4236 of the battery isolation protrusion 4235 isconfigured to be removably disposed between the second surface 4966 ofthe battery assembly 4962 and the contact portion 4918 of the distal endportion 4916 of the battery clip 4910, as described above.

FIGS. 26-29 show the safety lock 4700 of the medical injector 4000. Thesafety lock 4700 of the medical injector 4000 includes a proximalsurface 4740, a distal surface 4760 opposite the proximal surface 4740and a needle sheath 4720. The safety lock 4700 defines a needle sheathaperture 4770 and a battery isolation protrusion aperture 4775. Thebattery isolation protrusion aperture 4775 is configured to receive thebattery isolation protrusion 4235 of the cover 4200 such that thebattery isolation protrusion 4235 can be disposed within the electroniccircuit system cavity 4153 or the electronic circuit system 4900, asdescribed above. Similarly stated, the battery isolation protrusionaperture 4775 of the safety lock 4700 is aligned with the batteryisolation protrusion aperture 4121 of the housing 4110, such that thebattery isolation protrusion 4235 can be disposed within the electroniccircuit system cavity 4153 when the cover 4200 is disposed about aportion of the housing 4110.

The proximal surface 4740 of the safety lock 4700 includes a safety lockprotrusion 4742, a stopper 4743, an actuator 4744 and two opposing pulltabs 4741. As described above, when the safety lock 4700 is in a first(locked) position, the safety lock protrusion 4742 is configured to bedisposed in the opening 4554 defined by the extensions 4552 of thedistal end portion 4544 of the release member 4540. Accordingly, thesafety lock protrusion 4742 is configured to prevent the extensions 4552from moving closer to each other, thereby preventing proximal movementof the release member 4540 of the medicament delivery mechanism 4500and/or delivery of a medicament. The stopper 4743 of the safety lock4700 is a protrusion extending from the proximal surface 4740 of thesafety lock 4700. The stopper 4743 is configured to contact a portion ofthe housing 4110 to limit the proximal movement of the safety lock 4700relative to the housing 4110. In other embodiments, the stopper 4743 canbe any structure configured to limit the proximal movement of the safetylock 4700.

The actuator 4744 of the safety lock 4700 has an elongated portion 4745and a protrusion 4746. The elongated portion 4745 extends in a proximaldirection from the proximal surface 4740. In this manner, the elongatedportion 4745 can extend through a safety lock actuator opening 4356 ofthe base 4300 (see e.g., FIG. 30) and within the safety lock actuatorgroove 4123 of the housing 4110 and the safety lock actuator groove 4182of the electronic circuit system housing 4170. The protrusion 4746extends in a direction substantially transverse to the elongated portion4745 and/or substantially parallel to the proximal surface 4740 of thesafety lock 4700. As described above, the opening 4928 of the firstactuation portion 4926 is configured to receive the protrusion 4746 ofthe actuator 4744 of the safety lock 4700.

The pull tabs 4741 of the safety lock 4700 include a grip portion 4747and indicia 4748. The grip portion 4747 of the pull tabs 4741 providesan area for the user to grip and/or remove the safety lock 4700 from therest of the medicament delivery system 4700. The indicia 4748 providesinstruction on how to remove the safety lock 4700. In some embodiments,for example, the indicia 4748 can indicate the direction the user shouldpull the safety lock 4700 to remove the safety lock 4700.

As shown in FIG. 28, the needle sheath 4720 of the safety lock 4700includes a distal end portion 4724, a proximal end portion 4722 and aplurality of ribs 4728. The needle sheath 4720 can also define a lumen4729. The lumen 4729 of the safety lock 4700 is configured to receivethe needle 4512. In this manner, the needle sheath 4720 can protect theuser from the needle 4512 and/or can keep the needle 4512 sterile beforethe user uses the medical injector 4000. The proximal end portion 4722of the needle sheath is configured to contact the distal end portion4522 of the carrier 4520 of the medicament delivery mechanism 4500.

The distal end portion 4724 of the needle sheath 4720 has an angledridge 4725. The angled ridge 4725 is configured to allow the proximalend portion 4722 of the needle sheath 4720 to irreversibly move throughthe needle sheath aperture 4770 of the safety lock 4700 in a distaldirection. Said another way, the angled ridge 4725 can be configured insuch a way as to allow the proximal end portion 4722 of the needlesheath 4720 to move through the needle sheath aperture 4770 in a distaldirection, but not in a proximal direction. The needle sheath aperture4770 has retaining tabs 4771 configured to engage the proximal end ofthe angled ridge 4725 when the needle sheath 4720 is moved in a proximaldirection. In this manner, the retaining tabs 4771 prevent the proximalmovement of the needle sheath with respect to the safety lock 4700.Further, the retaining tabs 4771 are configured to engage the proximalend of the angled ridge 4725 when the safety lock 4700 is moved in adistal direction. Said another way, as shown in FIG. 33, the needlesheath 4720 is removed from the needle 4512 when the safety lock 4700 ismoved in a distal direction with respect to the housing 4110.

FIGS. 30-31 show the base 4300 of the medical injector 4000. The base4300 includes a proximal surface 4310, a distal surface 4330 and baseconnection knobs 4358. The base 4300 defines a needle aperture 4350, asafety lock protrusion aperture 4352, a battery isolation protrusionaperture 4354, a safety lock actuator opening 4356, and pull tabopenings 4360. The needle aperture 4350 is configured to receive theneedle 4512 when the medical injector 4000 is actuated. The safety lockprotrusion aperture 4352 of the base 4300 receives the safety lockprotrusion 4742 of the safety lock 4700. The battery isolationprotrusion aperture 4354 of the base 4300 receives the battery isolationprotrusion 4235 of the cover 4200 and the stopper 4743 of the safetylock 4700. The safety lock actuator opening 4356 receives the safetylock actuator 4744 of the safety lock 4700. The pull tab openings 4360are configured to receive the pull tabs 4741 of the safety lock 4700.

The proximal surface 4310 of the base 4300 includes an actuator 4311,guide members 4312, and protrusions 4313. The actuator 4311 is anelongate member configured to engage the substrate 4924 of theelectronic circuit system 4900. As described above, the opening 4945 ofthe second actuation portion 4946 is configured to receive the actuator4311 of the base 4300. The guide members 4312 of the base 4300 areconfigured to engage and/or slide within the base rail grooves 4127 ofthe housing 4110, as described above. The protrusions 4313 of the base4300 are configured to engage the tapered surfaces 4549 of theextensions 4552 of the release member 4540. As described in furtherdetail herein, when the safety lock 4700 is removed and the base 4300 ismoved in a proximal direction with respect to the housing 4110, theprotrusion 4313 of the base 4300 are configured to move the extensions4552 of the release member 4540 closer to each other, actuating themedicament delivery mechanism 4500. As described above, the baseconnection knobs 4358 are configured to engage the base retentionrecesses 4125A, 4125B in a way that allows proximal movement of the base4300 but limits distal movement of the base 4300.

As shown in FIG. 32, the medical injector 4000 is first enabled bymoving the medicament delivery device from a first configuration to asecond configuration by moving the cover 4200 from a first position to asecond position. The cover 4200 is moved from the first position to thesecond position by moving it with respect to the housing 4110 in thedirection shown by the arrow EE in FIG. 32. When the cover 4200 is movedwith respect to the housing 4110 in the direction EE, the batteryisolation protrusion 4235 is removed from the area between the batteryclip 4910 and the second surface 4966 of the battery assembly 4962. Inthis manner, the battery assembly 4962 can be operatively coupled to theelectronic circuit system 4900 when the cover 4200 is removed, therebyproviding power to the electronic circuit system 4900.

When power is provided, as described above, the electronic circuitsystem 4900 can output one or more predetermined electronic outputs. Forexample, in some embodiments, the electronic circuit system 4900 canoutput an electronic signal associated with recorded speech to theaudible output device 4956. Such an electronic signal can be, forexample, associated with a .WAV file that contains a recordedinstruction instructing the user in the operation of the medicalinjector 4000. Such an instruction can state, for example, “remove thesafety tab near the base of the auto-injector.” The electronic circuitsystem 4900 can simultaneously output an electronic signal to one and/orboth of the LEDs 4958A, 4958B thereby causing one and/or both of theLEDs 4958A, 4958B to flash a particular color. In this manner, theelectronic circuit system 4900 can provide both audible and visualinstructions to assist the user in the initial operation of the medicalinjector 4000.

In other embodiments, the electronic circuit system 4900 can output anelectronic output associated with a description and/or status of themedical injector 4000 and/or the medicament contained therein. Forexample, in some embodiments, the electronic circuit system 4900 canoutput an audible message indicating the type of medicament contained inthe medical injector 4000, the expiration date of the medicament, thedosage of the medicament or the like.

As described above, the medical injector 4000 can be repeatedly movedbetween the first configuration and the second configuration when thecover 4200 is moved repeatedly between the first position and the secondposition respectively. Said another way, the cover 4200 can be removedand replaced about the housing 4110 any number of times. When the cover4200 is moved from the second position to the first position, thebattery isolation protrusion 4235 is inserted between the battery clip4910 and the second surface 4966 of the battery assembly 4962,deactivating the electronic circuit system 4900. When the cover is movedfrom the first position to the second position a second time, theelectronic circuit system 4900 is once again activated. In this manner,the cover 4200 can be removed and the electronic circuit system 4900 canoutput an electronic output without compromising the sterility of theneedle 4512.

After the cover 4200 is removed from the housing 4110, the medicalinjector 4000 can be moved from the second configuration to a thirdconfiguration by moving the safety lock 4700 from a first position to asecond position. The safety lock 4700 is moved from a first position toa second position by moving the safety lock 4700 with respect to thehousing 4110 in the direction shown by the arrow FF in FIG. 33. When thesafety lock 4700 is moved from the first position to the secondposition, the safety lock protrusion 4742 is removed from between theextensions 4552 of the release member 4540, thereby enabling themedicament delivery member 4500. Moreover, as shown in FIGS. 21 and 22,when the safety lock 4700 is moved from the housing 4110, the actuator4744 of the safety lock 4700 moves in the direction CC as shown in FIG.22, irreversibly moving the first switch 4972 from a first state (e.g.,a state of electrical continuity) to a second state (e.g., a state ofelectrical discontinuity). When the actuator 4744 of the safety lock4700 moves irreversibly the first switch 4972 of the electronic circuitsystem 4900 to the second state, the electronic circuit system 4900 canoutput one or more predetermined electronic outputs. For example, insome embodiments, a processor (not shown) can output an electronicsignal associated with recorded speech to the audible output device4956. Such an electronic signal can be, for example, associated with arecorded message notifying the user of the status of the medicalinjector 4000. Such a status message can state, for example, “Themedical injector is now enabled.” The electronic circuit system 4900 canalso simultaneously output an electronic signal to one and/or both ofthe LEDs 4958A, 4958B, thereby causing one and/or both of the LEDs4958A, 4958B to stop flashing, change color or the like.

In some embodiments, the first actuation portion 4926 and the actuator4744 can be configured such that the actuator 4744 must move apredetermined distance before the actuator 4744 engages the boundary4929 of the opening 4928. For example, in some embodiments, the actuator4744 must move approximately 0.200 inches before the actuator 4744engages the boundary 4929 of the opening 4928. In this manner, thesafety lock 4700 can be moved slightly without irreversibly moving thefirst switch 4972 of the electronic circuit system 4900 to the secondstate. Accordingly, this arrangement will permit the user toinadvertently and/or accidentally move the safety lock 4700 withoutactuating the electronic circuit system 4900.

In some embodiments, the electronic circuit system 4900 can beconfigured to output the status message for a predetermined time period,such as, for example, five seconds. After the predetermined time periodhas elapsed, the electronic circuit system 4900 can output an audiblemessage further instructing the user in the operation of the medicalinjector 4000. Such an instruction can state, for example, “Place thebase of the auto-injector against the patient's thigh. To complete theinjection, press the base firmly against the patient's thigh.” In someembodiments, the electronic circuit system 4900 can simultaneouslyoutput an electronic signal to one and/or both of the LEDs 4958A, 4958B,thereby causing one and/or both of the LEDs 4958A, 4958B to flash aparticular color. In this manner, the electronic circuit system 4900 canprovide both audible and/or visual instructions to assist the user inthe placement and actuation of the medical injector 4000. In someembodiments, the electronic circuit system 4900 can be configured torepeat the instructions after a predetermined time period has elapsed.

As described above, in other embodiments, the medical injector 4000 canhave a network interface device (not shown) configured to operativelyconnect the electronic circuit system 4900 to a remote device (notshown) and/or a communications network (not shown). In this manner, theelectronic circuit system 4900 can send a wireless signal notifying aremote device that the safety lock 4700 of the medical injector 4000 hasbeen removed and that the medical injector 4000 has been armed.

After the safety lock 4700 is moved from the first position to thesecond position, the medical injector 4000 can be moved from the thirdconfiguration to a fourth configuration by moving the base 4300 from afirst position to a second position. The base 4300 is moved from itsfirst position to its second position by placing the medical injector4000 against the body of the patient and moving the base 4300 withrespect to the housing 4110 in the direction shown by the arrow GG inFIG. 34. Moving the base 4300 from the first position to the secondposition causes the protrusions 4313 on the proximal surface 4310 of thebase 4300 to engage the tapered surfaces 4549 of the extensions 4552 ofthe release member 4540, causing the release member 4540 to actuate themedicament delivery mechanism 4500 and deliver a medicament to a body ofa patient.

When the base 4300 is moved from the first position to the secondposition, the medicament delivery mechanism 4500 is actuated such thatthe puncturer 4541 of the release member 4540 is brought in contact withand/or punctures the frangible seal 4573 of the gas container 4570. Insome embodiments, the movement of the release member 4540 can be causedby a spring (not shown in FIG. 12). After the frangible seal 4573 hasbeen punctured, an actuating portion of a compressed gas can escape fromthe gas container 4570 and flow via the gas passageway 4144 into themedicament cavity 4157. The gas applies gas pressure to the movablemember 4530 causing the movable member 4530 and the carrier 4520 to movein a distal direction within the medicament cavity 4157. When thecarrier 4520 moves distally within the medicament cavity 4157, thecarrier 4520 and the medicament container 4560 are in a firstconfiguration. Accordingly, as described above, the medicament container4560 is connected to the carrier 4520 by a “snap fit” connection. Inthis manner, the medicament container 4560 and the needle 4512contemporaneously move with movable member 4530 and/or the carrier 4520in a distal direction. As described above, the proximal end portion 4516of the needle 4512 is connected to the distal end portion 4522 of thecarrier 4520 and is spaced from the seal 4523 of the medicamentcontainer 4560 when the carrier 4520 is in its first configuration. Saidanother way, the medicament container 4560 and the needle 4512 do notdefine a medicament delivery path when the carrier 4520 is in the firstconfiguration. The movement of the needle 4512 in a distal directioncauses the proximal end portion 4516 of the needle 4512 to exit thehousing 4110 and enter the body of a patient prior to administering amedicament.

After the carrier 4520 and/or the needle 4512 have moved within themedicament cavity 4157 a predetermined distance, the carrier 4520 andthe medicament container 4560 are moved from the first configuration toa second configuration. In the second configuration of the carrier 4520,the medicament container 4560 is released from the “snap-fit” allowingthe medicament container 4560 and the movable member 4530 to continue tomove in a distal direction relative to the carrier 4520. Said anotherway, the medicament container 4560 is configured to slidably move withinthe carrier 4520 when the carrier is moved from the first configurationto the second configuration. As the medicament container 4560 continuesto move within the carrier 4520, the proximal end portion 4516 of theneedle 4512 contacts and punctures the seal 4523 of the medicamentcontainer 4560. This allows the medicament contained in the medicamentcontainer 4560 to flow into the lumen (not shown) defined by the needle4512, thereby defining a medicament delivery path.

As the medicament container 4560 contacts the distal end of the carrier4520, the medicament container 4560 stops moving within the carrier 4520while the movable member 4530 continues to move in a distal direction.This causes the piston portion 4534 of the movable member 4530 tosealingly slide and/or move within the medicament container 4560containing a liquid medicament. As the piston portion 4534 of themovable member 4530 sealingly slides and/or moves within the medicamentcontainer 4560, the piston portion 4534 generates a pressure upon themedicament contained within the medicament container 4560, therebyallowing at least a portion of the medicament to flow out of themedicament container 4560 and into the lumen defined by the needle 4512.The medicament is delivered to a body of a user via the medicamentdelivery path defined by the medicament container 4560 and the needle4512.

As described above, the actuator 4538 of the base 4300 actuates theelectronic circuit 4900 to trigger a predetermined output or sequence ofoutputs when the base 4520 is moved from its first position to itssecond position (see, e.g., FIGS. 19-23). When the actuator 4538 ismoved in a proximal direction relative to the opening 4945, as shown bythe arrow DD in FIG. 23, the electronic circuit system 4900 is actuatedto output one or more predetermined electronic outputs. For example, insome embodiments, the electronic circuit system 4900 can output anelectronic signal associated with recorded speech to the audible outputdevice 4956. Such an electronic signal can be, for example, associatedwith an audible countdown timer, instructing the user on the duration ofthe injection procedure. Said another way, if it takes, for example, tenseconds to complete an injection, an audible countdown timer can countfrom ten to zero ensuring that the user maintains the medical injector4000 in place for the full ten seconds. In other embodiments, theelectronic signal can be, for example, associated with a recordedmessage notifying the user that the injection is complete, instructingthe user on post-injection disposal and safety procedures, instructingthe user on post-injection medical treatment or the like. Such a statusmessage can state, for example, “The injection is now complete. Pleaseseek further medical attention from a doctor.” The electronic circuitsystem 4900 can also simultaneously output an electronic signal to oneand/or both LEDs 4958A, 4958B, thereby causing one and/or both LEDs4958A, 4958B to stop flashing, change color or the like, to provide avisual indication that the injection is complete. In other embodiments,the electronic circuit system 4900 can send a wireless signal notifyinga remote device that the injection is complete. In this manner, apatient's compliance can be monitored.

In some embodiments, the second actuation portion 4946 and the actuator4538 can be configured such that the base 4500 and/or the actuator 4538must move a predetermined distance before the actuator 4538 engages theboundary 4949 of the opening 4945. For example, in some embodiments, theactuator 4538 must move approximately 0.200 inches before the actuator4538 engages the boundary 4949 of the opening 4945. In this manner, thebase 4700 can be moved slightly without irreversibly moving the secondswitch 4973 of the electronic circuit system 4900 to the second state.Accordingly, this arrangement will permit the user to inadvertentlyand/or accidentally move the base 4500 without actuating the electroniccircuit system 4900.

FIG. 35 depicts a medicament delivery device 100 (e.g., any suitabledevice, such as the medicament injectors and/or simulated devicesdescribed above with reference to FIGS. 1-35), an adapter 120 and amonitor device 150. The medicament delivery device 100 can be pairedwith and/or cooperatively function with the adapter 120 and/or themonitor device 150 to “page,” locate and/or otherwise assist a patientand/or third party in determining the identity and/or location of themedicament delivery device 100. The monitor device 150 can be anysuitable device that is operable to send a signal to the adapter 120causing the adapter 120 to emit a sound or other signal. In this manner,the monitor device 150 and the adapter 120 can cooperatively function toalert the user to the location of the medicament delivery device 100. Inother embodiments, according to the methods described herein, themonitor 150 can produce an alarm (e.g., an audible alarm, a visual alarmor a vibratory alarm) to indicate a loss of communications with theadapter 120, thus alerting the user to the possibility that the user maybe forgetting to carry the adapter 120.

The adapter 120 can be coupled to the medicament delivery device 100.The adapter 120 can, for example, be a sleeve, case, insert, attachment,and/or docking station coupled to the medicament delivery device 100, ahousing of the medicament delivery device 100 (such as the housing 4100described above) and/or electronic circuitry of the medicament deliverydevice 100 (such as the electronic circuit system 4900 described above).In some embodiments, the adapter 120 can be removably coupled to andsubstantially surround a portion of the medicament delivery device 100,similar to the covers 14200 and/or 4200 shown and described herein. Inother embodiments, an adapter 120 can be attached to an outer surface ofa medicament delivery device 100 without surrounding or covering asignificant portion of the medicament delivery device. In yet otherembodiments, an adapter 120 can be inserted completely or partially intoan inside chamber of a medicament delivery device. In yet otherembodiments, an adapter 120 can be fixedly coupled to an outer surfaceof a medicament delivery device. Although shown as being a separatecomponent, in some embodiments, an adapter 120 can be integral with themedicament delivery device 100. Said another, in some embodiments, thefunction of the adapter 120 described below can be included within ahousing and/or electronic circuit system of the medicament deliverydevice 100.

The adapter 120 can include a radio 122 (also referred to as a receiver,transmitter and/or transceiver) and/or an audible output device 124. Theradio 122 of the adapter 120 can be operable to send signals to, and/orreceive signals from the monitor device 150 in accordance with any ofthe methods described herein. For example, although not shown in FIG.35, in some embodiments, the adapter 120 can include a processor, amemory, a communication module, a leash module and/or a use module, asdescribe above with respect to FIG. 1.

The audible output device 124 of the adapter 120 can be operable to emitan audible output, such as a tone and/or recorded speech instructions.As discussed in further detail herein, in some embodiments, the adapter120 can include a sensor (or switch) 126 operable to detect an eventassociated with the medicament delivery device 100. Such events caninclude, for example, when the medicament delivery device 100 is usedand/or is prepared for use. In this manner, the sensor 126 can detectthe status and/or usage history of the medicament delivery device 100.For example, in some embodiments, the adapter 120 can be a sleeve orcover (similar to the cover 4200 shown and described above) that isremoved from the medicament delivery device 100 prior to use. In suchembodiments, the sensor and/or switch 126 can be operable to detect theremoval the adapter 120 from the medicament delivery device 100 and cancause the adapter 120 to send a signal (e.g., to the monitor device 150)via the radio 122 and/or to emit an audible output via the audibleoutput device 124. In some embodiments, as described herein, the adapter120 can adjust a communication mode, a communication interval, and/or apower level associated with a wireless communication between the adapter120 and the monitor device 150. In this manner, the adapter 120 can beconfigured to conserve power resources when the medicament deliverydevice 100 is coupled to and/or disposed within the adapter (i.e., themedicament delivery device 100 is otherwise not armed for and/or likelyto be used).

In some embodiments, the adapter 120 can include an electronic circuitsystem, similar to the electronic circuit system 4900 shown anddescribed above, to contain, include and/or provide interconnectionbetween the components discussed herein (e.g., the radio 122, theaudible output device 124 and the sensor 126). For example, in someembodiments, the adapter 120 can include an electronic circuit systemhaving one or more switches of the type disclosed above with referenceto the electronic circuit system 4900.

Although described as producing an audible output, in other embodiments,any of the devices and/or systems described herein can produce a humanperceivable signal, such as audible, visual, vibratory and/or hapticalerts. In other embodiments, the signal can be a radio signal, IRsignal and/or signals otherwise not human perceivable. An embodiment caninclude both human perceivable and signals that are not humanperceivable. For example, in some embodiments, the removal of themedicament delivery device 100 from the adapter 120 can place a powersource (not shown) of the medicament delivery device 100 in electricalcommunication with an electrical circuit. When “powered on,” themedicament delivery device can produce a signature pressure wave output(either audible or inaudible) that is detected by microphone on theadapter. As described in more detail herein, in response to the receiptof this signal, the adapter 120 can adjust a characteristic of thewireless communications therefrom. The medicament delivery device 100can further be configured to produce a second pressure wave (e.g., anaudible output) to provide instructions to the user, as described above.

The monitor device 150 can include a radio 152, an audible output device154, and/or one or more sensors 156, and can be operable to monitor theuser via the sensor 156, communicate with the adapter 120, and/orprovide an audible output. The monitor device 150 need not include allof the components shown in FIG. 35 nor perform all of the functionsdescribed herein. For example, in some embodiments, a locator accordingto an embodiment can be devoid of a sensor 156. The monitor device 150can be operable to be easily located, identified and/or readilyaccessible by the user and/or third parties. For example, the monitordevice 150 can be a bracelet, a necklace, a keychain fob, a watch, aring, an adhesive patch, a cellular phone or other personal electronicdevice, and/or any other suitable object. The monitor device 150 can bea piece of jewelry and/or integrated into a piece of jewelry. In someembodiments, however, the monitor device 150 can be inconspicuous, so asto not draw attention to the user. For example, in some embodiments, themonitor device 150 can be similar to and/or incorporated within anarticle that is inconspicuous. For example, in some embodiments, themonitor device 150 can be located on an inner layer of clothing,incorporated or manufactured as a part of the clothing, incorporatedinto a common accessory, fabricated to resemble a standard key fob, orthe like. In other embodiments, the monitor device 150 can beconspicuous such that, in the event of a medical emergency, bystanderscan readily identify and/or locate the monitor device 150, which can, inturn, allow the bystander to identify and/or locate the medicamentdelivery device 100. In yet other embodiments the monitor device 150 canbe configured to transition between an inconspicuous configuration and aconspicuous configuration. Similarly, stated, in some embodiments themonitor device 150 can be inconspicuous in a standby state, e.g., whenthere is no medical emergency, and conspicuous in an active state, e.g.,when there is a medical emergency, and/or when activated by the user.For example, the monitor device 150 can emit an alert, such as an alarmor recorded instruction via the speaker 154 and/or can have flashinglights, vibration (haptic output) and/or any other suitable mechanism todraw attention when the monitor device 150 is in the active (orconspicuous) state. Similarly stated, the monitor device 150 can includeany suitable mechanism for changing between a first configuration and asecond configuration in response to an event (e.g., a medical emergency,a notification received from a doctor, pharmacy or the like).

In some embodiments, the monitor device 150 can be a computing devicesimilar to the computing device 1510 described above. In suchembodiments the computing device (e.g., a smart phone) can be adapted toperform the functions of the monitor device 150 as described herein. Forexample, a cellular telephone can execute an application operable tomonitor the user via the sensor 156, communicate with the adapter 120,and/or provide an audible output via the audible output device 154.

The monitor device 150 can communicate with the adapter 120 via theradio 152. The communication between the monitor device 150 and theadapter 120 can be initiated by any suitable method, including manualinitiation and/or automatic initiation. In some embodiments, thecommunication between the monitor device 150 and the adapter 120 can beinitiated by pushing a button. In other embodiments, the monitor device150 can be activated by a signal from the sensor 156 and/or the sensor126. In this manner, for example, the communication can be initiatedwhen the sensor 156 detects a significant change in the user's vitalsigns. In some embodiments, the monitor device 150 and the adapter 120can establish and maintain a substantially continuous and/orperiodically verified communications link. If the link is severed, e.g.,the monitor device 150 moves out of communications range from theadapter 120, the monitor device 150 and/or the adapter 120 can emit asignal, such as an audible or visual alarm, to alert the user to thebroken connection. Such an embodiment could reduce the likelihood of theuser forgetting to carry the adapter 120 and/or the monitor device 150together.

In some embodiments, as described herein, characteristics of thecommunication between the monitor device 150 and the adapter 120 can bemodified in response to a signal received from the sensor 156, thesensor 126, a manual entry or the like.

In use, the monitor device 150 and the adapter 120, can cooperativelyfunction to aid the user in identifying and/or locating the adapter 120,which can, in turn, aid the user in locating the medicament deliverydevice 100. For example, when actuated the monitor device 150 can send asignal, e.g., via the radio 152, to the adapter 120 to cause the adapter120 and/or the medicament delivery device 100 to emit ahuman-perceivable signal, such as an audible or visual alert. The humanperceivable signal can be operable to draw the user's attention to theadapter 120.

In some embodiments, the monitor device 150 and/or the adapter 120 canbe operable to calculate and/or report a distance between and/or adirection of the locator relative to the adapter 120. For example, theadapter 120 and/or the monitor device 150 can be operable to calculatetheir respective positions (e.g., absolute positions or positionrelative to each other), for example based on the strength and/ordirection of a radio signal, triangulation, trilateration, GPS, or anyother suitable means. In such embodiments, the monitor device 150 candirect the user to the location of the adapter 120 based on thecalculation of the relative positions. This arrangement can allow, forexample, the monitor device 150 and/or the adapter 120 to produce adynamic alert based on the change in position of the monitor device 150and the adapter 120. For example, in some embodiments, the adapter 120can emit a pulsed audible output when communication with the monitordevice 150 is established. Based on the calculated relative positionand/or distance between the adapter 120 and the monitor device 150, anintensity, frequency and/or magnitude of the audible output can change.In particular, the frequency and/or magnitude of the audible output(e.g., a beep) can get higher and/or louder as the monitor device 150 ismoved closer to the adapter 120 (and/or the medicament delivery device100). In this manner the adapter 120 and/or the monitor device 150 caninclude and/or operate as a proximity detector.

In some instances, a person requiring administration of a medicament, “apatient,” may not be the person administering the delivery of themedicament (referred to herein as “a user”). For example, the medicamentcontained in the medicament delivery device 100 may be intended foradministration in a medical emergency, during which the patient may beincapacitated. For example, in some embodiments, the medicament deliverydevice (e.g., the medicament delivery device described above withreference to FIGS. 3-34) may be intended to deliver epinephrine in theevent of an anaphylactic crisis, or to deliver naloxone in the event ofan opioid overdose, or any other potentially life-saving medication. Insuch an emergency, the patient may not be able to operate the medicamentdelivery device 100. Accordingly, as described herein, in suchcircumstances, the monitor 150 can detect the presence of a medicalcondition (e.g., via sensor 156), can produce an instruction, alert orother notification (e.g., via the audible output device 154), and caneither prompt the third party care giver to initiate communication withthe adapter 120 or automatically establish such communications. Forexample, in some embodiments the sensor 156 can be operable to detectphysiological parameters associated with the patient, such as heartrate/pulse, respiratory rate, blood sugar, blood oxygen, blood or tissuelactate level, blood or tissue ketone level, an immune response,acceleration (e.g., associated with a fall), brain activity, and/or thelike. In the event the monitor device 150 detects an abnormal conditionthat may require medical attention, the monitor device 150 can emit asignal to be received by the adapter 120, such that the adapter canprovide an indication, instruction or the like as discussed herein.

In some embodiments, the monitor device 150 and any of the monitoringdevices, adapters and/or locators described herein can be configured tosend a wireless signal in response to the detection of an abnormalcondition or potential emergency. In particular, in some embodiments,the monitor device 150 and/or any device operably coupled thereto canautomatically dial an emergency number such as, for example, 911(emergency dispatcher), and/or send information associated with thelocation of the device and/or the end user location through GPSsatellite positioning or network based positioning (using cell phonetowers). In this manner, the adapter 120, the monitor device 150 and anremote device (not shown in FIG. 35) can form a network, as describedabove with reference to FIG. 1.

In other embodiments, the monitor device 150 can be triggered by anon-emergency event. For example, in some embodiments, the sensor 156can be configured to measure environmental conditions or the like (e.g.,temperature, humidity, presence of certain allergens, etc.) andestablish communications with the adapter 120 based on suchmeasurements. For example, in some embodiments, the medicament deliverydevice 100 can be an inhaler, and the monitor device 150 can measure andanalyze environmental data such that the monitor device 150 can alertthe patient and/or user to use the inhaler.

Although the monitor device 150 is shown as including a sensor 156, inother embodiments, the monitor device 150 need not include any sensors.For example, in some embodiments, the monitor device 150 be conspicuousand/or include a conspicuous label such that a third party willrecognize the monitor device 150, and can then manually initiatecommunication with the adapter 120 (e.g., by pressing a switch, similarto actuating a “page” feature). For example, in some embodiments, themonitor device 150 can include a conspicuous start button that, whenpushed, results in a message being produced by the monitor device 150.The message can state, for example, “THE PERSON WEARING THIS IDENTIFIERIS CARRYING AN AUTO-INJECTOR TO TREAT SYMPTOMS RELATED TO . . . IF THISPERSON IS EXHIBITING SUCH SYMPTOMS, PLEASE LOCATE THE AUTO-INJECTOR,WHICH IS NOW BEEPING, AND FOLLOW THE NEXT SET OF INSTRUCTIONS.”

Although the adapter 120 is shown as being a separate component that iscoupled to a medicament delivery device 100 (e.g., such a sleeve, andadapter, or the like), in other embodiments, the functionality of theadapter 120 can be incorporated into the medicament delivery device 100,such that the monitor device 150 communicates and/or interacts directlywith the medicament delivery device 100 to perform the functionsdescribed herein.

Although shown as interacting with a single medicament delivery device100, in other embodiments, an adapter 120 can interact with more thanone medicament delivery device 100. In other embodiments, a monitordevice 150 can interact with more than one adapter 120 and/or medicamentdelivery device 100. For example, FIG. 36 shows a medicament deliverysystem including a locator 250, a first adapter 220A that can beoperable to interact with a medicament delivery device 200 and a secondadapter 220B that can be operable to interact with a medicamentcontainer 260. The locator 250 can include a radio 252, an audibleoutput device 254, and/or one or more sensors 256, and can be operablecommunicate with the adapter 220A and the adapter 220B, and/or providean audible output, in a similar manner as described above with referenceto the monitor device 150, and as described below.

In particular, the locator 250 can communicate with the adapter 220A toconfirm the existence of, identify and/or locate the medicament deliverydevice 200, as described above with reference to the monitor device 150and adapter 120. Thus, the adapter 220A can include any of the structureand components, and can function similar to any of the adaptersdescribed herein. In this manner, in the event of a medical conditioninvolving the medicament in the medicament container 260 (e.g., anoverdose), the adapter 220A can assist the user (or patient) in locatingthe medicament delivery device 200. In addition, because the locator 250is in communication with the adapter 220B, the locator 250 and/or theadapter 220B can, as described below, provide compliance and/orhistorical information related to the use of the medicament in themedicament container 260 (e.g., how many pills were recently removedfrom the container), as well as instructions and/or assistance inidentifying and/or locating the medicament delivery device 200.

The adapter 220B includes a sensor 226 to monitor location, use history,fill level and/or any other suitable parameter associated with themedicament container 260 and/or the medicament delivery device 200. Inthis manner, when the locator 250 is activated (e.g., by a user), thelocator and the adapter 220B can provide information to the userregarding the status of the medicament. In addition to assisting in thelocation of the medicament delivery device 200, providing suchinformation can be important in determining the appropriate course ofaction. For example, in some embodiments, the adapter 220B can beoperably coupled to the medicament container 260, and the sensor 226 canbe operable to determine, measure, record, and/or otherwise monitor thecontents and/or the use of the medicament container 260. In someembodiments, the sensor 226 can measure the weight, volume, quantity,and/or any other appropriate parameter of the medicament within themedicament container 260. The sensor 226 can be an optical sensorconfigured to align with a window of the medicament container 260 tomeasure color, fill level, turbidity, and/or any other suitableparameter. In some embodiments, the sensor 226 can detect when the capof the medicament container 260 is removed, when the medicament isadministered, the amount of medicament in the medicament container 260,withdrawal of medicament from the medicament container 260, and/orchanges in the volume and/or mass of the contents of the medicamentcontainer 260. In this manner, the adapter 220A can provide the user, anemergency first responder, and/or any other person information regardingthe contents and/or usage history of the medicament container 260.

In one example, the medicament container 260 includes a pain medication,such as opioids. In the event of a serious opioid toxicity or overdoseemergency, information regarding the identity and usage history of theopioids may be relevant to the treatment of the patient. If the patienthas recently received a large dose of opioids, it may be necessary totreat the patient for an overdose, for example by administering anopioid antagonist. By monitoring the medicament container 260, theadapter 220B (either alone or in conjunction with the locator 250) canalert a user (e.g., a third party) if treatment is needed. The adapter220B can cooperatively function with the locator 250, the medicamentdelivery device 200 (and/or the adapter 220A or sleeve of the device) toproduce a signal and/or indication identifying and/or locating themedicament delivery device. In particular, the adapter 220A, the adapter220B and/or the locator 250 can produce and signals and/or provide anyindications in a similar manner as the adapter 120 and/or the monitordevice 150 described above. For example, the adapter 220A and/or thelocator 250 can also instruct the user to use the medicament deliverydevice 200, which can include the opioid antagonist.

In another example, the medicament delivery device 200 and/or themedicament container 260 can include a dose of vaccine, such as ahepatitis B or HPV vaccine to be administered within a certain timeperiod. The sensor 226 of the adapter 220B can be operable to monitorthe storage time and/or temperature of the medicament delivery device200 and/or the medicament container 260 to improve the likelihood thatan efficacious dose of medicament is delivered. If the medicamentdelivery device 200 and/or the medicament container 260 is not usedwithin a predetermined time period, the adapter 220B can alert the userand/or a care-giver, such as a prescribing doctor, healthcare provider,or insurance company that the medicament has not yet been delivered. Forexample, the adapter 220B can emit an audible and/or visual alert, e.g.,via the audible output device 224. In addition or alternatively, theadapter 220B can send an electronic signal via the radio 222 operable toalert the user and/or healthcare provider (either directly to a remotedevice, such as a smart phone, or via the locator 250).

In some embodiments, the adapter 220B and/or the adapter 220A can beoperable to receive a signal via the radio 222 (although the radio 222is not shown as being included within the adapter 220A, it is understoodthat the functionality of the adapter 220A can be the same as or similarto the functionality of the adapter 220B). In some embodiments, forexample, the healthcare provider can remotely query the adapter 220regarding the status and/or use history of the medicament deliverydevice 200 and/or medicament container 260. In this way, the healthcareprovider can determine whether the medicament delivery device 200 and/orthe medicament container 260 has been used within the predetermined timeperiod and/or can schedule follow-up contact and/or care based on theuse of the medicament delivery device 200 and/or the medicamentcontainer 260.

In some embodiments, the locator 250 and/or the adapter 220B can beincluded within and/or can be a portion of a container within which themedicament container 260 is disposed (e.g., for storage, shipping or thelike). For example, in some embodiments the medicament container 260 canbe disposed within the adapter 220B, such that the sensor 226 and/or theother components of the adapter 220B are operably coupled to themedicament container 260. In other embodiments, the adapter 220B can becoupled to and/or can be a portion of the medicament container 260. Forexample, the adapter 220B can be a cap of the medicament container 260,an insert for the medicament container 260, a dispenser for themedicament container 260, a sleeve, a case, and/or label of themedicament container 260.

In some embodiments, the system can include the adapter 220B that iscoupled to the medicament container 260 external to the housing ormedicament contained therein. For example in some embodiments theadapter 220B can be a sleeve and/or label of the medicament container260. In other embodiments, the system can include an adapter 220B thatis coupled within the medicament container 260. For example, in someembodiments, the adapter 220B can be included within a desiccant packagecontained within the medicament container 260, on an interior surface ofthe medicament container 260. Similarly, the adapter 220A can be coupledto, included within and/or can be a portion of the medicament deliverydevice 200. For example, in some embodiments, the adapter 220A can be amouth piece that is removably coupled to an inhaler. In otherembodiments, the adapter 220A can be a cover that is removably coupledto a nasal delivery system

Although not shown in FIG. 36, the adapter 220A can include any of thefunctionality of the adapter 220B described above. For example, theadapter 220A can include a sensor and/or a switch to determine aparameter associated with of operation of the medicament delivery device200. For example, in some embodiments, the adapter 220A can be coupledto an inhaler (or other multi-dose device), and can track the patient'scompliance in using the device. In this manner, the adapter 220A and/orthe adapter 220B can function, either independently, in conjunction witheach other and/or in conjunction with the locator 250 as “smart sleeves”to improve the efficacy of the dosages contained in either themedicament container 260 or the medicament delivery device 200.

Although described, at least in part, as relating to an emergencysituation, the systems and methods described herein can be easilyextended to non-emergency situations. For example, in a chronic-caresetting a patient can purchase an initial kit that includes the adapters220A and 220B, and one or more locators 250 configured to communicatewith the adapters, as described herein. The user can removably couplethe adapter 220B to the medicament container 260 and/or the adapter 220Ato the medicament delivery device 200, such that upon refilling themedication, the appropriate adapter can be coupled to the replacementmedicament container 260 and/or medicament delivery device 200.

Although the medicament container 260 and the medicament delivery device200 are described above as being separate (although related inapplication), in some embodiments, the medicament container 260 can bedisposed within the medicament delivery device 200. For example, themedicament container 260 can be a vial of medicament disposed within anddelivered by an auto injector, inhaler, and/or other suitable medicamentdelivery device 260. In another embodiment, the medicament container 260can be operable to refill and/or replenish the medicament deliverydevice 200. For example, the medicament container 260 can transfermedicament to the medicament delivery device 200 or, although only onemedicament container 260 is shown, in some embodiments, a kit canmultiple medicament containers 260 (refills). In other embodiments, themedicament container 260 can be used in conjunction with and/orindependently from the medicament delivery device 200. For example, themedicament container 260 can include medicament related to, but notadministered via the medicament delivery device 200. For example, themedicament container 260 can include opioids and the medicament delivery200 device can be operable to deliver an opioid antagonist, such asnaloxone, naltrexone or the like, in the event of a severe opioidtoxicity or overdose event.

Although the adapter 220A and the adapter 220B are shown ascommunicating through the locator 250, the devices shown and describedherein can communicate in a peer-to-peer fashion.

FIG. 37 is a front view of a cover 14240 (also referred to as anadapter, sheath or sleeve) for a medicament delivery device (not shown).The cover 14240 includes an electronic circuit system having a processor14246, a radio 14243, and a speaker 14248. In some embodiments, theprocessor 14246, the radio 1424314243, and the speaker 14248 can all bedisposed on a single printed circuit board. In some embodiments, thecover 14240 can include a battery, such as a coin-cell battery operableto power the processor 14246, the radio 1424314243, and the speaker14248. The batteries can be, for example, lithium coin cells modelCR1613, CR 2032 or the like. The cover 14240 can be an adapterconfigured to be coupled to a medicament delivery device, and canperform the functions of the adapter 1210 and/or the sleeve 4200described above (or any combination of the functions thereof). Forexample, the cover 14240 can define a cavity 14242 operable to receivethe medicament delivery device. In some embodiments, the medicamentdelivery device (not shown) can include its own electronic circuitsystem, similar to the circuit system 4900 shown and described above. Insome such embodiments, the cover 14240 and the medicament deliverydevice can each have separate power sources.

The processor 14246 can be any suitable processor. For example, theprocessor 14246 can be structurally and/or functionally similar to theprocessor 1216 as shown and described above with reference to FIG. 1.For example, the processor 14242 can be a Bluetooth® Low Energyprocessor (e.g., of the type shown in FIG. 2) configured to operate theradio 1424314243 to communicatively couple the cover 14240 to acomputing device. In addition or alternatively the processor 14246 canbe operable to perform speech processing and/or operate the speaker14248, for example to generate an audible output, such as a speechoutput (of the types and in response to the inputs as described herein).Similarly stated, a processor having a single die can be suitable tooperate the radio 1424314243 and the speaker 14248.

Although not shown in FIG. 37, in some embodiments, the adapter 12240can include any of the modules described herein. For example, in someembodiments, the adapter 12240 can include any of a communicationmodule, a use module and/or a leash module as described above withrespect to FIG. 1. Thus, the processor 14246 can execute code to modifyone or more characteristics of the wireless communication between theradio 14243 and a computing device (e.g., a cell phone, not shown) tomanage the power usage of the cover 14240. For example, in someembodiments, the processor 14246 can execute code to change thecommunication mode between the cover 14240 (i.e., the “slave” device)and a computing device (i.e., the “master” device) as a function of thestatus of the medicament delivery device.

Moreover, in some embodiments power management techniques, such as timemultiplexing can be executed by the processor 14246. Such powermanagement methods can be performed, for example, by a power module (notshown in FIG. 37). For example, the processor 14246 can be operable tomanage power draw such that high-draw and/or processor intensiveoperations, such as voice processing and operating the radio 14243 arenot executed simultaneously. For example, in some embodiments, a methodcan include delaying and/or extending a communication interval during atime period when operations involving a recorded speech output via thespeaker 14248 and/or a light output device (not shown) are performed. Inother embodiments, a method can include changing a communication modeduring a time period when operations involving a recorded speech outputvia the speaker 14248 and/or a light output device (not shown) areperformed. For example, in some embodiments, a method can includetransitioning the device to a sniff or park mode upon activation of thedevice to conserve power draw from the instruction features of thedevice.

As shown and described with reference to FIGS. 1, 35 and 36, in someembodiments, the cover 14240 can include a switch and/or a sensoroperable to detect, for example, when the medicament delivery device isremoved from the cover 14240 and/or when medicament delivery device isactuated. In some embodiments, the processor 14246 can be operable tocause the speaker 14248 to generate an audible output, such as a tone ornatural speech output in response to the cover 14242 being removed fromthe medicament delivery device, in response to a signal received via theradio 14243, and/or in response to a sensor detecting the actuation ofthe medicament delivery device. In addition or alternatively, theprocessor 14246 can be operable transmit a signal via the radio 14243(e.g., to a computing device, not shown) in response to the cover 14240being removed from the medicament delivery device and/or in response toa sensor detecting the actuation of the medicament delivery device. Insome embodiment, the processor 14246 can be operable to alter acommunication interval and/or communication mode (e.g., from connectableto connected, from sniff to active, and/or from a relatively longercommunication interval to a relatively shorter communication interval)in response to the cover 14240 being removed from the medicamentdelivery device and/or a sensor detecting the actuation of themedicament delivery device. In this manner, the cover 14240 can conservethe power for situations in which wireless communications with theremote computing device is most likely.

In some embodiments, the cover 14240 can also interact with and/orinfluence the operation of an electronic circuit system of themedicament delivery device contained therein (e.g., medicament injector4000). For example, as shown and described herein, for example withreference to FIGS. 7, 9, and 25, the cover 14240 can include a batteryisolation tab. The battery isolation tab can be configured to isolate apower source (such as a battery) from an electronic circuit of themedicament delivery device when the medicament delivery device isdisposed within the cover 14240. Although shown and described withrespect to FIG. 25 as isolating the battery from the entire electroniccircuit system, in some embodiments, the battery isolation tab can beoperable to isolate a only a portion of a circuit while another portionof the circuit remains electrically coupled to the power source. Forexample, a “leaky” or “hi draw” portion of the circuit (i.e., a portionof the circuit having a relatively high power draw during idle) can beisolated from the battery, while a less leaky or essential portion ofthe circuit can remain powered. As one example, a portion of a circuitincluding a communication module, such as a Bluetooth® module, can becontinuously powered, while a portion of a circuit including an audioprocessor and/or speaker can be isolated. In some embodiments, such abattery isolation tab can be a multi-stage battery isolation tab, suchthat, for example, if the battery isolation tab is in a first positionthe battery is completely isolated from the circuit, if the batteryisolation tab is in a second position, a portion of the circuit isisolated while another portion of the circuit is electrically coupled tothe power source, and if the battery isolation tab is in a thirdposition, the full circuit is electrically coupled to the power source.

FIG. 38 is a signal diagram illustrating a series of communications thatcan be initiated and/or received by any of the devices and systemdescribed herein. The signal communications are operable to increase thelikelihood that a patient 3152 receives appropriate medical care in theevent of a medical emergency and/or during a dosing regimen. In theevent that the patient 3152 requires treatment and needs assistanceand/or is not able to operate a medicament delivery device 3100configured to provide the needed treatment, it may be necessary to alerta third-party bystander or emergency first responder (a user 3102). Asdescribed herein, the alert can include a notification of the presenceof the medicament delivery device 3100 and/or provide the user 3102instructions for the use of the medicament delivery device 3100. Asshown in FIG. 38, a system includes a monitoring device 3150, a adapter3120 and/or a communication device 3122 that cooperatively aid thepatient 3152 and/or the user 3102 in identifying the medical emergency,locating the medicament delivery device 3100, administering the neededtreatment, and/or reporting the medical emergency. Although FIG. 38shows each of the monitoring device 3150, the adapter 3120, themedicament delivery device 3100 and/or the communication device 3122, insome embodiments certain functions attributed to one of these devicescan be performed by any other of these devices. Moreover, a system andmethod according to an embodiment need not include each of thesedevices.

Each of the monitoring device 3150, the adapter 3120, the medicamentdelivery device 3100 and/or the communication device 3122 can beoperable to send and/or receive signals. The signals can be humanperceivable, such as audible, visual, vibratory and/or haptic alerts. Inother embodiments, the signals can be electromagnetic signals, radiosignals, IR signals and/or signals otherwise not human perceivable. Anembodiment can include both human perceivable and signals that are nothuman perceivable.

As shown by the signal 3210, the monitoring device 3150 is operablycoupled to the patient 3152 and can send and/or receive the signal 3210.More particularly, the monitoring device 3150 is operable to sense whenthe patient 3152 requires the administration of a medicament, e.g., fromthe medicament delivery device 3100, and can produce the signal 3210 inresponse thereto. The monitoring device 3150 can be, for example, asensor operable to detect physiological parameters associated with thepatient 3152, such as heart rate/pulse, respiratory rate, blood sugar,blood oxygen, an immune response, acceleration (e.g., associated with afall), brain activity, and/or the like. In some embodiments, themonitoring device 3150 can be similar to the monitor device 150 and/orthe locator 250 described above, or any of the other locators describedbelow. For example, in some embodiments, the monitoring device can beintegrated with and/or coupled to a piece of jewelry (e.g., a ring,watch, belt buckle, or necklace) worn by the user, or the like.

In the event the monitoring device 3150 detects a condition that mayrequire medical attention, the monitoring device 3150 can emit thesignal 3220 operable to alert the patient 3150 and/or the signal 3220 toalert the user 3102 to the abnormal condition. Signals 3220 and/or 3230can be an audible and/or visual alert, such as an alarm, a strobinglight, and/or a recorded instruction. If the patient 3152 is capable ofresponding the condition (e.g., the patient 3152 is not incapacitated)the patient 3152 can silence the alarm and/or administer the necessarytreatment (e.g., using the medicament delivery device 3100). If,however, the patient 3152 is incapable of responding to the condition(e.g., the patient 3152 is incapacitated), the signal 3230 can notifythe user 3102 that the patient 3152 requires medical attention, that themedicament delivery device 3100 is present, provide instructions forusing the medicament delivery device 3100, and/or instructions forobtaining further information related to the medicament delivery device3100.

In addition to producing the signals 3220 and 3230, the monitoringdevice 3150 can produce the signal 3240 to communicate with an adapter3120, which can be coupled to or integral with the medicament deliverydevice 3100. The adapter 3120 can be similar to the locator devices 120and/or 220 shown and described above. In some embodiments, the adapter3120 can be incorporated into a sleeve within which at least a portionof the medicament delivery device 3100 is disposed (e.g. similar to thesleeve 4200 shown and described above with reference to FIGS. 3-34). Theadapter 3120 can facilitate communication with and/or identification ofthe medicament delivery device 3100 in accordance with any of themethods described herein.

As described herein, the monitoring device 3150 and the adapter 3120 cancooperate to aid the user 3102 in locating the medicament deliverydevice 3100. For example, signal 3240 can cause the adapter 3120 to emitan audible or visual alert operable to draw the user's 3102 attention,and/or the monitoring device can be operable to ascertain the locationof the adapter 3120, e.g., via radio location techniques, and emit anoutput operable to guide the user to the adapter 3120. For example, themonitoring device 3150 can emit a tone and/or chirp that varies inpitch, frequency, and/or volume as the distance between the monitoringdevice 3150 and the adapter 3120 changes. In this way, the adapter 3120can be operable to guide the user 3102 to the medicament delivery device3100.

As shown as signal 3250, the medicament delivery device 3100 can provideinstructions to the user 3102 and/or can direct the user 3102 to obtaininstructions for the use of the medicament delivery device 3100. Forexample, the instruction can any of the electronic instructionsdescribed herein, such as electronic output OP1 and/or OP2 shown anddescribed above with reference to the medicament delivery device 4000.In some embodiments, signal 3250 can include recorded instructionsregarding the use of the medicament delivery device 3100. In someembodiments, after the medicament delivery device is located, a visualoutput in the form of LCD Display output can direct the user regardinginstructions for using the device.

In some embodiments, either the patient 3152 and/or the user 3102 canpossess the communication device 3122, and the system and/or thecommunication device 3122 can be adapted and/or enabled to perform allor portions of the functions of the monitoring device 3150, the adapter3120 and/or the medicament delivery device 3100. In this manner, thesystem and methods can utilize the communication resources that arecommonly available. In particular, in some embodiments, thecommunication device 3122 can be a smart phone or other portableelectronic device (pager, game system, music system or the like). Insuch embodiments, the systems described herein can be configured toemploy the communication resources (e.g., the speakers, displaycapabilities, signal processing, transmission/reception capabilities, orthe like) of the communication device 3122 to enhance the performance ofthe overall system.

For example, in some embodiments, the medicament delivery device 3100,the monitoring device 3150 and/or the adapter 3120 can include a labelhaving a machine-readable code. The machine-readable code can be, forexample, a bar code, a QR Code™ and/or an address of a website. Duringan event, the user can scan or otherwise read the machine-readable codeusing the communication device 3122 (e.g., a cellular phone) to accessinstructions. For example, in some embodiments, upon scanning themachine-readable code, the user's cellular phone will be directed to awebsite or other location in which instructions for using the medicamentdelivery device 3100 and/or otherwise treating the patient are provided.In other embodiments, the label can include a text message prompting theuser to scan the machine-readable code with the patient's communicationdevice 3122. In a similar manner, the patient's communication device canbe directed to a website or other location in which instructions forusing the medicament delivery device 3100 and/or otherwise treating thepatient are provided 3122. Moreover, the patient's communication device3122 can include information unique to the patient, such as, forexample, a listing of contacts to reach in the event of an emergency (insome embodiments, by scanning the machine-readable code, a text messagewill automatically be sent to this list), an application stored locallythat provides detailed instructions unique to the patient or the like.

In other embodiments, the communication device 3122 can enable the user3102 to access the patient's 3152 medical history, provide patientspecific instructions, and/or prompt the user 3102 to notify emergencypersonnel and/or the patient's 3152 emergency contact. For example, insome embodiments, upon detection of an event, the patient'scommunication device 3122 can emit a ring tone prompting the user 3102to access the communication device 3122. Upon accessing the patient'scommunication device 3122, the user 3102 can receive signals and/orinformation related to the patient's medical history or the like.

In other embodiments, the communication device 3122 (e.g., either theuser's mobile computing device or the patient's mobile computing device)can be configured to receive a signal (not shown) from the medicamentdelivery device 3100 and/or the adapter 3120. The signal can bereceived, for example, after the communication device 3122 is used toscan a label, tag or other machine-readable code on the medicamentdelivery device 3100 and/or the adapter 3120. In other embodiments, thesignal can be received automatically (e.g., without the need to scan acode), for example, in response to the manipulation of the medicamentdelivery device 3100. Upon receiving the signal, the communicationdevice 3122 can then transmit visual and audible instructions for usingthe medicament delivery device 3100. In some embodiments, for example,the medicament delivery device 3100 and/or the adapter 3120 can includean electronic circuit system similar to the electronic circuit system4900 shown and described above, except that instead of producing anoutput via LED's (e.g., LED 4958A and 4958B) and/or an audible outputdevice (e.g., device 4956), the electronic circuit system produces awireless signal in response to actuation of the switches therein (e.g.,switches 4926 and 4946). In some embodiments, the wireless signal can bereceived by the communication device 3122 (e.g., either the user'smobile computing device or the patient's mobile computing device). Thecommunication device 3122 can then, in turn, produce the audible andvisual instructions in response to manipulation of the medicamentdelivery device 3100. This arrangement allows the computing and/orcommunication resources of the communication device 3120 to be used toenhance the instructions, locating capabilities and/or the like of thesystems described herein.

Although FIG. 38 is shown and described as having a separate monitoringdevice 3150 and adapter 3120, in some embodiments, some or all of thefunctions of the monitoring device 3150 and the adapter 3120 can becombined in a single device. For example, as shown in FIG. 39, a systemcan include and/or employ a cellular phone 6122 operable to communicatewith the medical delivery device 6100 (e.g., via Bluetooth®). Thecellular phone 6122 can also be configured to communicate with thepatient 6152 and/or the user 6102 (e.g., via audio or visual outputs),and the medicament delivery device 6100 (e.g., via Bluetooth®) to aidthe patient 6152 and/or the user 6102 in identifying, locating and/orusing the medicament delivery device 6100. The medicament deliverydevice 6100 can be similar to the medicament delivery devices shown anddescribed above. The locator device 6120 can be similar to the locatordevices shown and described above, and/or can be integrated into themedicament delivery device or cover (e.g., the sleeve 4200).

For example, the functions of the monitoring devices described above canincorporated into the patient's cell phone 6122 (as indicated by theinclusion of the monitoring device 6150). For example, the monitoringdevice 6150 can be operable to sense when the patient 6152 requires theadministration of a medicament. As described above with reference toFIG. 38, the monitoring device 6150 can be operably coupled to monitorthe patient 6152, as shown by the arrow 6210. The monitoring device 6150can comprise sensors incorporated into and/or operatively coupled to thecell phone 6122, such as accelerometers, gyroscopes, and/or peripheraldevices, such as heart rate monitors. Upon detecting a condition, thepatient's 6152 cell phone can alert the patient 6152 (via signal 6220)and/or the user 6102 (via signal 6230). For example, in someembodiments, the cell phone 6122, can emit an audible, visual, and/orhaptic signal to draw the attention of the patient (e.g., signal 6220)and/or the user (signal 6230). Signals 6220 and/or 6230 can instruct thepatient 6152 and/or the user 6102, respectively, that the patient 6152requires medical attention.

In some embodiments, the system can include one or more sensors externalto the cell phone 6122, but which are coupled to the cell phone, eitherwireless or via a wired connection. For example, in some embodiments thepatient 6152 may wear a monitoring device, such a glucose meter, a heartrate monitor or the like. Although such external devices may produce anaudible alarm, the systems and methods described herein allow thepatient's cell phone 6122 to act as a central “hub” to receive suchsignals, produce an enhanced output, communicate with the medicamentdelivery device 6100 or the like.

The cell phone 6122 can also be operable to display e.g., via a visualoutput device, or emit, e.g., via an audible output device, informationand/or instructions regarding the patient's medical history and/or theadministration of medicament using the medicament delivery device 6100.The cell phone 6122 can also automatically contact emergency personneland/or prompt the patient 6152 and/or the user 6102 to contact emergencypersonnel.

For example, in some embodiments, the cell phone 6122 (either thepatient's cell phone or the user's cell phone) can execute anapplication (e.g., in hardware) that can unlock and/or otherwiseconfigure the cell phone 6122 to be used by the patient 6152 and/or theuser 6102. In some embodiments, the cell phone 6122 can automaticallydisplay a prompt and/or instruction upon detecting a specifiedcondition. Thus, the cell phone 6122 can be configured to be useableand/or provide information to the user 6102 in the event of a medicalemergency without requiring a password or unlock sequence. For example,in some embodiments, the touch screen of the cell phone 6122 can displaya button in response to the detection of a specified condition thatprompts a user (e.g., a third party) to enter the application. In otherembodiments, the cell phone 6122 can display a message prompting theuser to “swipe,” scan or read a particular code thereby unlocking thecell phone for subsequent use as described herein. For example, in someembodiments, the user can be prompted to swipe, scan or read anidentification card, another device, a medicament container or the like.

The cell phone 6122 can aid the user 6102 in administering medicament tothe patient 6152 using the medicament delivery device 6100. For example,the cell phone 6122 can send a signal 6240 to the medicament deliverydevice 6100 to aid the user 6102 in locating the medicament deliverydevice 6100. The cell phone 6122 can provide instructions to assist theuser 6102 in administering a medicament to the patient 6152 via themedicament delivery device 6100. In addition, the cell phone 6122 canalso send a signal to administer the medicament without the userinterfacing with the medicament delivery device 6100.

Although the locators (e.g., monitor device 150) are shown and describedabove as being “wearable” items, such as a key fob, jewelry or the like,in other embodiments a locator can be a substantially stationary item.Moreover, although the locators (e.g., monitor device 150) are shown anddescribed above as being unique to a particular patient, in otherembodiments, a locator can be used to track multiple different patients,users or care-givers and/or to communicate with multiple differentdevices (either different devices of the same type or different devicesof different types). Such a locator can be used, for example, in aninstitutional setting (schools, nursing homes, hospitals or the like) orin a public access setting (restaurants, airports, health clubs or thelike) to improve the ability of patients and user to identify, locateand/or actuate a variety of different medicament delivery devices.Moreover, in some embodiments, a locator can, in addition to performingthe identification and/or location features described herein, serve toprevent unauthorized and/or undesired access to medicaments. Forexample, FIGS. 40-42 depict a kit (or container) 300 according to anembodiment. The kit 300 includes a medicament container 360 containingany suitable medicament. The kit 300 can be intended for home and/orinstitutional use and can be wall-mounted and/or otherwise substantiallyfixed in a particular location. The kit 300 can store and/or dispense amedicament (e.g., from within the medicament container). In someembodiments, the kit 300 can dispense an opioid and/or provide accesscontrol for an opioid or other controlled substance.

The kit 300 also includes a movable portion 318, such as, for example, ahinged lid, that has a first position (see FIG. 40) and a secondposition (see FIGS. 41-42). When the movable portion 318 is in the firstposition, the movable portion 318 covers an internal region 312 definedthe kit 300. Conversely, when the movable portion 318 is in the secondposition, at least a portion of the internal region 312 of the kit 300is exposed. Said another way, when the movable portion 318 is in thesecond position, the medicament container 360 can be removed from theinternal region 312 of the kit 300.

The container or kit 300 includes an electronic circuit system 322 thatis operatively coupled to and/or includes a radio 324, a first switch336, and a second switch 337. The switches can be operably coupled toany suitable mechanism. In particular, the first switch 336 is coupledto a lock mechanism (not shown) that, when in the locked configuration,will prevent the movable portion 318 from being moved into the openedposition. The electronic circuit system 322 is includes an actuator orother mechanism configured to cause the first switch 336 to move betweena first state (e.g., closed) and a second state (e.g., opened) when theradio 342 receives a signal from an access control device 310 and/or theelectronic circuit system 322 validates the signal. When the firstswitch 336 is in its second state (e.g., opened) the locking mechanismis “unlocked” such that the movable portion 318 can be moved between itsfirst position and its second position, as indicated by arrow E in FIG.41. In this manner, the patient or user can only access the medicamentcontainer when the access control device 310 is present and ismanipulated to send the access signal.

The access control device 310 can be, for example an RFID device. Theelectronic circuit system 322 can log information associated with theaccess control device 310, such as a unique identifier (e.g., when thekit 300 is configured to be accessed by more than one user each having aunique access control device 310), time of access, number of accessattempts, time between access attempts, etc. In some embodiments, theelectronic circuit system 322 can be configured to only allow access tothe contents of the kit 300 (e.g., only move the first switch 336 fromthe first state to the second state) at certain times, after certainintervals, and/or to certain individuals. The radio 324 can transmit asignal associated with usage history to, e.g., a remote monitoringdevice (such as a computer), and/or receive and respond to a queryregarding usage history.

As an example, the medicament container 360 can include a controlledsubstance and/or a medicament with potentially dangerous side effects,such as an opioid. This arrangement limits access to the medicamentcontainer 360 the identity of the user (e.g., via the access controldevice 310), based on time, past usage, and/or quantity. In someembodiments, access to the medicament container 360 can also be limitedto patients having a medicament delivery device (e.g., an auto-injector)containing an opioid antagonist. In this manner, the system ensuresaccess to the opioid only when there exists the likelihood that rapidtreatment will be available in the event of an overdose (i.e., via thepresence of the medicament delivery device in close proximity to a user,patient or care-giver). In such an embodiment, the medicament deliverydevice containing the opioid antagonist can be or include the accesscontrol device 310. The medicament delivery device can include, forexample, an RFID chip detectable by the radio 324. When the patientpresents the medicament delivery device (the access control device 310),the electronic circuit system can identify the user and determinewhether to grant access to the medicament.

The second switch 337 is configured to move between a first state (e.g.,closed) and a second state (e.g., opened) when the medicament container360 is removed from the internal region 312 of the kit 300, as indicatedby the arrow F in FIG. 42. The electronic circuit system 330 can beconfigured to log the removal of the medicament container 360 inresponse to the changing state of the switch. The electronic circuitsystem can associate the removal of the medicament container 360 with auser identifier provided by the access control device 310. In someembodiments, second switch 337 can be operable to determine the quantityof medicament removed from the interior region 312 of the kit.

In some embodiments, the electronic circuit system 330 can be configuredto cause the radio 324 to transmit a signal associated with the removalof the medicament container 360 from the interior region 312 of the kit300. For example, in some embodiments, the kit 300 can communicate witha computer (not shown) to log medicament usage and/or send notifications(e.g., notify medical providers, notify emergency personnel, notifypre-programmed contact personnel, etc.).

In some embodiments, the electronic circuit system 330 can be configuredto output an audible and/or visual output, for example via a speakerand/or an LCD screen when the second switch 337 is moved from its firststate to its second state, for example, a recorded speech output and/ora video output associated with an identification of the medicamentcontainer 360, an identification of patient symptoms (e.g., instructionsfor assessing the physical condition of the patient) and/or aninstruction for using the medicament. For example, in some embodimentsthe output can be an audio-visual output via both a speaker and an LCDscreen step-by-step instructions for using the medicament.

Although the movable member 318 is shown and described as being a hingedlid, in some embodiments, the movable member can be coupled to thecontainer in any suitable fashion. For example, in some embodiments, themovable member 318 can be a removable cover that is slidingly coupled tothe container. In other embodiments, the movable member 318 can be aremovable cover that is threadedly coupled to the container (i.e., aremovable cap). In yet other embodiments, the movable member 318 can bea removable cover that is coupled to the container via an interferencefit. In yet other embodiments, the movable member 318 can be a frangiblecover that is irreversibly removed from the container during use of themedical device. For example, in some embodiments the movable member 318can be a frangible cover that provides a tamperproof seal, a sanitaryseal, or the like.

Although the containers, kits and/or adapters are shown and described insome instances above as being rigid, box-like containers, in otherembodiments, a container, kit and/or adapter can have any suitable shapeand/or flexibility. For example, in some embodiments, a container, kitand/or adapter can be a flexible, pouch-like container. Such acontainer, kit and/or adapter can be more easily carried in certaincircumstances, such as, for example at outdoor events (e.g., children'scamps, concerts, picnics or the like). In other embodiments, acontainer, kit and/or adapter can be a tube or sheath (e.g., similar tothe cover 4200 described above) configured to contain all or a portionof a medicament delivery device 360.

Although FIGS. 40-42 depict and describe a medicament container 360removable from the interior region 312 of the container or kit 300, inother embodiments, the kit 300 can be operable to dispense medicamentwithout a container 360. For example, the kit 300 can be operable todispense medicament tablets, pills, capsules, liquid, aerosols, and/orany other suitable medicament form. In such embodiments, the movablemember 318 can be a dispensing mechanism configured to meter a quantityof medicament. For example, the moveable member 318 and/or the secondswitch 337 can be operable to count and dispense an appropriate numberof pills. The moveable member 318 and/or the second switch 337 can alsoinclude a loss-in-weight meter, a volumetric pump, and/or any othersuitable mechanism for dispensing, metering, and/or measuring theremoval of medicament and/or medicament container(s) 360 from theinterior region 312.

In some embodiments, the medicament container 360 can be a medicamentdelivery device and/or the medicament container 360 can be disposedwithin a medicament delivery device. In such an embodiment, themedicament delivery device can be similar to the medicament deliverydevice 4000 shown and described above.

FIG. 43 depicts a schematic illustration of a medicament delivery device11002 operable to be coupled to a case or cover 11197. The medicamentdelivery device 11002 can be similar to the medicament delivery devicesshown and described above, such as medicament delivery device 4000. Thecase 11197 can be a case operable to be physically and/or electricallycoupled to the medicament delivery device 11002 and a communicationdevice 11990 (e.g., a cell phone). The case 11197 can be a sleeve (suchas the cover 4200 described above), a flexible pouch or the like. Thecase 11197 includes an electronic circuit system 11920. The electroniccircuit system 11920 can be any electronic circuit system of the typeshown and described herein. For example, the cover 11197 can bestructurally and/or functionally similar to the cover 14240 shown anddescribed above with reference to FIG. 37. For example, the electroniccircuit system 11920 can be configured to monitor the status of themedicament delivery device 11002, interact with (or be actuated by) toproduce a signal, actuate the medicament delivery device 11002, provideinstructions for using the medicament delivery device 11002 or the like.

In some embodiments, the medicament delivery device 11002 can include asafety guard that is moved prior to administering the medicament and anactuator that is moved to initiate delivery of the medicament. Thesafety guard can be similar to safety lock 4700 shown and describedabove. The actuator can be similar to the base 4300 shown and describedabove. In some embodiments, the medicament delivery device 11002 and/orthe case 11197 can detect that the medicament delivery device 11002 isready for use and send a signal to the communication device 11990. Inresponse, the communication device 11990 (e.g., the cell phone) canprovide instructions to the patient and/or user regarding the use of themedicament delivery device 11002. For example, in some embodiments,movement of the safety guard (to place the medicament delivery device11002 in a “ready” configuration) can trigger the electronic circuitsystem 11920, causing the case 11197 to “detect” the status of themedicament delivery device 11002. The case 11197 can then send a signalthat is received by the communication device 11990 such that anapplication running on the communication device 11990 providesinstructions. In some embodiments, the communication device 11990 can beoperable to send a signal, such as an alert to a pre-programmedemergency contact via the communication network 11999.

In some embodiments, the case 11197 can include sensors and/or canreceive signals from the medicament delivery device 11002. In thismanner, the case 11197 can transmit information associated with the useof the medicament delivery device 11002 to the communication device11990. The communication device 11990 can provide instructions to thepatient and/or user based on the status and/or a change in configurationof the medicament delivery device 11002. For example, the communicationdevice 11990 can provide different instructions associated with theremoval of a safety guard, positioning the medicament delivery device11002 and/or case 11197 against a body part, and/or triggering themedicament delivery device 11002 (e.g., movement of an actuator orbase).

In some such embodiments, the communication device 11990, the case11197, and the medicament delivery device 11002 can be communicativelycoupled such that the status and/or use of the medicament deliverydevice 11002 can be remotely monitored. For example, the case 11197 canbe operable to report the status of the medicament delivery device 11002to a remote server via the communication device 11990 and thecommunication network 11999.

In some embodiments, a case or cover can be configured to removablycontain at last a portion a medicament delivery device and acommunication device (e.g., a cell phone). In this manner, the case canoperably couple a medicament delivery device to an off-the-shelfcommunication device to produce a “smart” medicament delivery device.For example, FIGS. 44 and 45 are schematic diagrams of a case 21197coupled to a medicament delivery device 21990 and a cell phone 21002.The medicament delivery device can be similar to the medicament deliverydevice 4000 as shown and described above or any other suitable device.The case 21197 can define a first volume operable to contain themedicament delivery device 21990 and a second volume operable to containa cell phone 21002. Thus, the case 21197 can couple the medicamentdelivery device 21990 to the cell phone 21992, thereby increasing thelikelihood that the medicament delivery device 21990 is available in theevent that a medicament is needed.

The case 21197 contains an electronic circuit 21920. The electroniccircuit system 21920 can be operable to store, process and/or produceelectronic signals associated with the use of the medicament deliverydevice 21990. The electronic system 21920 can be similar to any of theelectronic circuit systems shown and described herein. Moreover, theelectronic system 21920 is communicatively coupled to the cell phone21002. The electronic system 21920 can be communicatively coupled to thecell phone 21002 via any suitable mechanism, such as, for example via awired configuration (via the docking port, USB port, or other port onthe cell phone 21002), via a physical connection (e.g., via a member,switch actuator or the like that transmits input to the cell phone 21002via the touch screen or other buttons on the cell phone 21002) orwirelessly via an RF or optical signal. In some embodiments, theelectronic circuit system 21920 can provide an input to the cell phone21002 via a microphone of the cell phone 21002. For example, in someembodiments, manipulation of the case 21197 and/or the medicamentdelivery device 21990 disposed therein (as described below) can resultin the electronic circuit system 21920 producing a pressure wave (eitheraudible or inaudible) having a particular frequency or pattern offrequencies that is detectable by the microphone. In this manner, theelectronic circuit system 21920 can trigger the cell phone to send asignal, run an application, or the like, based on the status and/orchange in configuration of the medicament delivery device 21990.

In some embodiments, the electronic circuit system 21920 can be operablycoupled to the medicament delivery device 21990. In some embodiments,the case 21197 and/or the electronic circuit system 21920 can bephysically, but not electronically coupled to the medicament deliverydevice 21990. In such an embodiment, the case 21197 can be operable tomonitor the status of (e.g., to receive input from) the medicamentdelivery device via physical changes and/or forces applied by or to themedicament delivery device 21990, as described in more detail herein.

The medicament delivery device 21990 includes a safety tab 21995 and anactuator 21997. The safety tab 21195 and the actuator 21997 can be, forexample, similar to the safety lock 4700 and the base 4300,respectively, shown and described above. As shown, in FIG. 44, a portionof the safety tab 21995 is disposed outside of the case 21997 prior touse of the medicament delivery device 21990. In this manner, althoughthe medicament deliver device 21990 is disposed within and/or is coveredby the case 21977, the user can prepare the medicament delivery device21990 for actuation by accessing the exposed portion of the safety tab21995. The safety tab 21995 can be removed before using the medicamentdelivery device 21990 as indicated by arrow G in FIG. 44. Moreover,removing the safety tab 21995 can cause the medicament delivery device21990 to change position (i.e., to a “ready position”) within the case21197. In this manner, a delivery member (e.g., a needle) of themedicament delivery device 21990 can be moved in proximity to theopening through which the safety tab 21995 was disposed, therebypreparing the device to deliver the medicament therein.

When the safety tab 21995 is removed, the medicament delivery device21990 can be secured in the ready position by a movable retainingportion 21924 of the case 21197. The retaining portion 21924 can be aspring-actuated tab, a deformable portion of the case 21197 or the likethat, upon movement of the proximal edge of the medicament deliverydevice 21990, is released to limit movement of the medicament deliverydevice 21990. Additionally, the electronic circuit 21920 can sense thatthe retaining portion 21924 has secured the medicament delivery device21990 in the ready position and can send a signal to the communicationdevice 21002. In response, the cell phone 21002 can provide aninstruction to the user and/or send a signal to a remote monitoringdevice, e.g., via a network, an emergency dispatch system (911 call) orthe like. For example, the cell phone 21002 can instruct the user toplace the case 21197 against the thigh and/or send a notification, suchas an SMS message to a pre-programmed emergency contact.

The electronic circuit 21920 can sense that the retaining portion 21924has secured the medicament delivery device 21990 via any suitablemechanism, such as, for example, a switch that is actuated upon movementand/or removal of the safety tab 21995, movement of the housing of themedicament delivery device 21990 or release and/or movement of theretaining portion 21924.

In some embodiments, the case 21197 can include a sensor 21992 (see FIG.45) operable to detect if the case 21197 and the medicament deliverydevice 21990 are positioned against the body of the user. Accordingly,the electronic circuit system 21920 can send a signal to thecommunication device 21002 when the sensor 21922 detects that the caseis properly positioned. In response, the communication device 21002 canprovide an instruction to the user and/or send a signal to a remotemonitoring device. For example, the communication device 21002 caninstruct the user to actuate the medicament delivery device and/or senda notification, such as an SMS message to a pre-programmed emergencycontact.

With the medicament delivery device 21990 in the ready position, asindicated in FIG. 45, the actuator 21997 is exposed and/or is disposedat least partially outside of the case 21997. In this manner, themedicament delivery device 21990 can be actuated by moving an actuator21997, as indicated by arrow H. Actuating the medicament delivery device21990 can cause it to deliver a medicament (e.g., as described abovewith reference to the device 4000). The electronic circuit system 21924can detect that the medicament delivery device 21990 has been actuated,for example, by detecting a force associated with actuation against theretaining portion 21924, and can provide an instruction to the userand/or send a signal to a remote monitoring device. For example, thecommunication device 21002 can instruct the user to seek medicalattention, and/or send a notification, such as an SMS message to apre-programmed emergency contact. In other embodiments, a portion of theactuator 21997 can actuate and/or contact a switch of the electroniccircuit system 21920 such that a signal is sent to the cell phone 21002.

In this manner, the electronic circuit system 21920 can send electronicsignals associated with the status, use, and/or other function of themedicament delivery device to and/or receive electronic signals from acommunications network via the cell phone 21002.

FIG. 46 is a flow chart of a method pairing an adapter with a computingdevice. The adapter (which can be coupled to and/or configured to becoupled to a medicament delivery device and/or a simulated device) andthe computing device can be structurally and/or functionally similar tothe adapter 1210 and/or the computing device 1510, as shown anddescribed above with reference to FIG. 1, or any other adapters anddevices shown and described herein. At 22010, the computing device canestablish a communication link according a wireless protocol, such as aBluetooth® link, with the adapter. In some embodiments, thecommunication link (or pairing of devices) can be maintainedindefinitely (e.g., as long as the adapter and the computing device arewithin range and both devices are powered). In other embodiments, thecommunication link (or pairing of devices) can time out after apre-determined time period, for example, if there is no data associatedwith the status and/or use of a medicament delivery device within thetime-period, which may be 1 hour, 1 day, 2 days, and/or any othersuitable time period.

In some instances, maintaining an active link can be more energyefficient than repeatedly linking with the adapter. In such an instanceit may be desirable to maintain the link. In some embodiments, the linkcan be maintained, but the computing device can instruct the adapter toenter a sniff or park mode or other suitable mode to conserve power.

At 22020, a signal associated with a use of and/or change inconfiguration of the medicament delivery device can be received from asensor. For example, the adapter can include a switch operable to detectwhen the medicament delivery device is removed from the adapter and/orwhen the medicament delivery device is armed (e.g., when a safety tab isremoved). In other embodiments, the adapter can include an opticalsensor to detect a change in status of the medicament delivery device(e.g., to detect a change in the opacity and/or color of the medicament,to detect removal from the adapter or the like). In yet otherembodiments, the adapter can include a microphone to detect a soundpressure wave associated with a change in the configuration and/orstatus of the medicament delivery device. Such a change in soundpressure wave can be produced by a mechanical feature (e.g., a signature“snap” sound when the medicament delivery device is removed) orelectronically (e.g., via a series of tones produced by the medicamentdelivery device when it is powered up).

In response, the computing device and/or the adapter can modify aparameter associated with the communication link, at 22030. For example,in some embodiments, a communication mode can be altered (e.g., from asniff mode in effect prior to receiving the signal to an active mode).In other embodiments, an advertising interval can be altered, and/or acommunication interval can be altered. For example, it may be desirableto decrease a communication interval (e.g., the time between successivesignals, portions of a signal and/or data packet transfers) when themedicament delivery device is readied for use to increase communicationbandwidth and/or decrease the latency of the connection. In this way,more data and/or more timely data can be transferred between the adapterand the paired computing device during the delivery of a medicament.

Optionally, at 22040 the computing device can receive an indication thatthe medicament delivery device was actuated. For example, the adaptercan include a sensor operable to detect the actuation of the medicamentdelivery device (which can be the same or a different sensor asdiscussed above). When the adapter senses the actuation, it can send asignal to the computing device, which can be received, at 22040. Inresponse to receiving the indication of the actuation, the computingdevice and/or the adapter can optionally produce an audible output, at22050. For example, the computing device output a verbal instructionthat a medicament has been delivered, instruction to contact a doctorand/or emergency response, instructions for follow-up care, and soforth. In addition or alternatively, the computing device can beoperable to send a signal to a remote device (e.g. similar to the remotedevice 1610 as shown and described with reference to FIG. 1) reportingthe actuation of the medicament delivery device. Furthermore, in anembodiment where the computing device is a mobile phone, the computingdevice can be operable to initiate a telephone call, for example, to911, an emergency contact, a doctor, etc.

FIG. 47 is a flow chart illustrating a leash method that can beimplemented by any of the leash modules shown and described herein. At22110, a computing device (which can be similar to the computing device1510) can establish a communication link, such as a Bluetooth® link,with the an adapter (which can be similar to the adapter 1210), amedicament delivery device and/or a simulated medicament deliverydevice. Once a link is established, the computing device can check,record, and/or report its location (e.g., via GPS), at 22120.

The communication link can be maintained while the computing device andthe adapter are within radio range. At 21130, the computing device canreceive an indication at a first time that the connection has been lost.The indication can include a failure to receive an acknowledgement of asignal sent to the adapter device, the failure of the adapter device tosend a data packet at an expected time, and/or any other suitableindication. In some instances, the indication of failure can beassociated with radio interference, in other instances, the failure canbe associated with a user carrying the computing device away from theadapter (or vice versa).

In embodiments where the adapter is coupled to or configured to becoupled to a medicament delivery device, it may be medically advisablethat the medicament delivery device be available to the user at alltimes. If a medicament delivery device is rarely used, however, the usermay have a tendency to forget to carry the medicament delivery devicewith him or her. The user may be much less likely to forget to carry amobile phone (e.g., computing device). Thus if the computing devicelosses contact with the adapter, it may be an indication that the userhas forgotten the medicament delivery device. The computing device canverify its location (e.g., via GPS), at 22140. If the location of thecomputing device is similar to the location received at 22120 (e.g.,within a predetermined distance), this can indicate that the user isstill near the adapter. Similarly, checking the location, at 22140 caninclude determining whether the computing device is located in a “home”region (e.g., a predetermined boundary or geographic area), which canindicate that the user is still near the adapter. The home region can bea predefined region, e.g., selected by the user. For example, thecomputing device can be operable to prompt or allow the user to define ahome region, which can be an area where the user is likely to haveaccess to a medicament delivery device (e.g., the user's house) and/orthe computing device can be operable to infer a home region, forexample, based on a common location of the computing device and/or acommon location of a computing device during a particular period (e.g.,the user can infer that a location of the computing device at 3:00 am isa home region).

If, the location of the computing device at 22140 is different from thelocation at 22120 (e.g., by 300 feet, 1000 feet, ½ mile, 5 miles, and/orany other suitable distance), and/or the location of the computingdevice at 22150 is outside the home region, this can indicate that themedicament delivery device has been left behind, and an alert can begenerated, at 22150. The alert can include an audible and/or visualalert to inform the user that connection has been lost. In addition oralternatively, the computing device can send a signal e.g., via WiFi ora cellular data network to a remote device, such that user compliancecan be tracked and/or monitored.

FIG. 48 is a flow chart of a method of operation of a simulatedmedicament delivery device, according to an embodiment. A simulatedmedicament delivery device (also referred to herein as a “trainer”) canbe used to train a user on the operation of an actual medicamentdelivery device. A simulated delivery device can be structurally and/orfunctionally similar to any of the medicament delivery devices describedherein, but may be devoid of a medicament a, needle, and/or componentsassociated with delivery of the medicament. A simulated medicamentdelivery device can include a processor, memory, a battery, sensorsand/or any other suitable components. In some embodiments a simulatedmedicament device can be resettable and/or reusable. A simulatedmedicament delivery device can be coupleable to an adapter, and/or caninclude any of the components of the adapters shown and describedherein. For example, a simulated medicament device can include aBluetooth® processor and can be operable to communicatively link with acomputing device, as described herein.

At 22160, an indication associated with a first operation of a simulatedmedicament delivery device can be received. For example, a simulatedmedicament delivery device can include one or more sensors and/orswitches operable to detect various operations, such as sensor operableto detect when a sleeve is removed, when a safety guard is removed, whenan actuator is manipulated, the position of the simulated medicamentdelivery device, and/or any other suitable operation. The indicationreceived, at 22160 can be any suitable operation associated with the useof a simulated medicament delivery device.

In response to receiving the indication, at 22160, an first audibleoutput can be generated, at 22170. The audible output can be associatedwith a first script, and can be an acknowledgement of the operation, aninstruction of a next operation, an instruction that an operation wasnot properly performed (e.g., operations performed out of sequence,operations performed with insufficient force, operations performed withthe simulated medicament delivery device in an improper orientation, aninstruction that the operation was not performed within an appropriateperiod of time, etc.), and so forth.

At 22180, information associated with the operation can be stored, forexample in a memory (e.g., a memory coupled to the simulated medicamentdelivery device, a memory of an adapter, a memory in a remote database,etc.) The information stored, at 22180, can include an indication ofwhich operation was performed, time data, orientation data, temperaturedata, and/or any other suitable information. The information stored, canbe used to improve the training of the user. For example, theinformation stored can reveal a pattern of improper use. At 22190, asecond script can be produced. The second script can, for example,reflect updated instructions based on errors identified from theinformation.

At 22195, a second audible output associated with the second script canoptionally be generated. The second audible output can be based oninformation stored, at 22180, and/or the second operation. In this way,the second audible output can be based on patterns (e.g., the firstoperation and the second operation), elapsed time, and/or any othersuitable characteristic. As an illustration, if the first operation andthe second operation are each attempted manipulations of the actuator,the indication received at 22160, and the indication received, at 22190,are each indications that insufficient force was applied, the secondscript, and the second audible output, at 22195 can include aninstruction that to apply additional force, as insufficient force hastwice been applied.

FIG. 49-51 are screenshots of instances of a user interface for anapplication. A processor, for example, a processor of a computing devicesuch as a mobile phone communicatively linked to an adapter and/ormedicament delivery device, can execute the application. The applicationcan provide a user information associated with status, location, use,etc.

For example, as shown in FIG. 49, in some instances, the application canprovide access to a trainer simulator, a demo video, writteninstructions, reminders and notifications, and/or a medicament deliverydevice monitor. For example, the instance of the application shown inFIG. 49 can enable a user to access a demonstration video. Such a videocan aid a user in properly using a medicament delivery device.Similarly, written instructions, can provide convenient access todetailed information associated with a medicament delivery device. Insome cases, owing to the size of a medicament delivery device, labelingreal estate may be at a premium. An application can provide additionalinformation, as well as interactive information, such as hyperlinks etc.The written instructions can also be updated remotely.

In addition, the application can be operable to provide reminders, forexample, if the user is scheduled to use the medicament delivery device.In embodiments where the computing device is communicatively linked tothe adapter, the application can receive signals from the adapterassociated with use of the medicament delivery device. In this way, areminder may only be issued if the user has not actually used themedicament delivery device according to a schedule.

The application can also generate alerts, for example if the medicamenthas expired, been recalled, or if the medicament delivery device hasexperienced a temperature unsuitable for the medicament. Any suitablemethods for tracking the temperature history of the medicament deliverydevice can be employed, such as, for example, those methods disclosed inU.S. Pat. No. 8,361,029, entitled “Devices, Systems and Methods forMedicament Delivery” issued Jan. 29, 2013, the disclosure of which isincorporated herein by reference in its entirety. Similarly stated, acomputing device can receive signals associated with the status of themedicament delivery device from the medicament delivery device and/orfrom a remote computing device and the application can notify the userof the status.

In some embodiments, the application can notify the user if themedicament delivery device is out of range, for example, generating analert as shown in FIG. 50. As shown and described above with referenceto FIG. 47, a lost communication link can be indicative that a user hasforgotten to carry the medicament delivery device. Similarly stated, insome embodiments a computing device, such as a mobile phone, can executethe method (e.g., at a processor) shown and described with reference toFIG. 47. In such an embodiment, an application can alert the user of thelost communication link.

FIG. 51 depicts an instance of an application operable to monitor amedicament delivery device. The application can be personalized, asrepresented by a depiction of an avatar 22210 or photo of the user. Theapplication can indicate a connection status 22220, for exampleindicating the presence and/or strength of a communication link. Theapplication can also display, for example based on information receivedfrom an adapter, information associated with the charge state 222230 ofa battery associated with the adapter and/or medicament delivery deviceand/or the current temperature 22240 of the medicament delivery deviceand/or temperature history of the medicament delivery device (which maybe relevant to medicament stability). Furthermore, the application canenable the user to send a signal to the adapter to cause the adapter toemit a sound 22250, which may aid the user in locating the medicamentdelivery device and/or can cause the computing device to useradio-location techniques to aid the user in locating the adapter 22260.

Some embodiments described herein relate to a computer storage productwith a non-transitory computer-readable medium (also can be referred toas a non-transitory processor-readable medium) having instructions orcomputer code thereon for performing various computer-implementedoperations. The computer-readable medium (or processor-readable medium)is non-transitory in the sense that it does not include transitorypropagating signals per se (e.g., a propagating electromagnetic wavecarrying information on a transmission medium such as space or a cable).The media and computer code (also can be referred to as code) may bethose designed and constructed for the specific purpose or purposes.Examples of non-transitory computer-readable media include, but are notlimited to: magnetic storage media such as hard disks, floppy disks, andmagnetic tape; optical storage media such as Compact Disc/Digital VideoDiscs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), andholographic devices; magneto-optical storage media such as opticaldisks; carrier wave signal processing modules; and hardware devices thatare specially configured to store and execute program code, such asApplication-Specific Integrated Circuits (ASICs), Programmable LogicDevices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM)devices.

Examples of computer code include, but are not limited to, micro-code ormicro-instructions, machine instructions, such as produced by acompiler, code used to produce a web service, and files containinghigher-level instructions that are executed by a computer using aninterpreter. For example, embodiments may be implemented usingimperative programming languages (e.g., C, Fortran, etc.), functionalprogramming languages (Haskell, Erlang, etc.), logical programminglanguages (e.g., Prolog), object-oriented programming languages (e.g.,Java, C++, etc.) or other suitable programming languages and/ordevelopment tools. Additional examples of computer code include, but arenot limited to, control signals, encrypted code, and compressed code

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, although electronic circuit systems are shown and describedabove as outputting one or more outputs directed towards a single,immediate user, in some embodiments, a locator device and/or monitoringdevice can output multiple outputs directed towards multiple differentclasses of users. For example, in some embodiments, the locator deviceand/or monitoring device can output a first output to the immediate userand second output to a remotely located emergency response team. In suchembodiments, the second output can be, for example, a phone call, SMS, apage, an e-mail or the like. For example, in some embodiments, thesecond output can be an e-mail to the parents and/or care-givers of achild. Moreover, such a second output can be transmitted eitherwirelessly or through a wired network.

Although the electronic circuit systems are shown and described above asoutputting one or more outputs in response to one or more switches, inother embodiments an electronic circuit system can output an electronicoutput in response to any number of different inputs. For example, insome embodiments, an electronic circuit system can output an electronicoutput based on input from the user provided via a keyboard, a touchscreen, a microphone or any other suitable input device. In this manner,the electronic outputs can be produced in response to direct feedbackfrom the user.

The adapters, medicament delivery devices and simulated medicamentdelivery devices are described herein as being configured to produce oneor more wireless signals in accordance with the methods describedherein. Although the methods and apparatus are described herein as beingconfigured to modify the communication mode and/or the communicationinterval associated with such wireless signals in response to a changein the status and/or configuration of a device (e.g., a medicamentdelivery device or a simulated medicament delivery device), in otherembodiments, any of the apparatus and methods described herein canmodify any aspect of the wireless signals based on such change in statusand/or configuration. For example, in some embodiments a method caninclude modifying a power level of a wireless signal in response to achange in status and/or configuration of a medicament delivery device ora simulated medicament delivery device. In other embodiments, a methodcan include modifying the information contained within a wireless signalin response to a change in status and/or configuration of a medicamentdelivery device or a simulated medicament delivery device. For example,in some embodiments, a wireless signal can include informationassociated with a signal power level (e.g., TX Power) and/or anidentification of a device. Such information can be changed in responseto a change in status and/or configuration of a medicament deliverydevice or a simulated medicament delivery device.

In some embodiments, information included within a signal can includeinstructions to initiate a natural language user interface associatedwith (or running on) another device. Thus, any of the apparatus andmethods described herein can be configured to send and/or can includethe sending of a signal to initiate a natural language user interfaceassociated with a remote computing device. For example, in someembodiments, the adapter 120 can be configured to send a wireless signalto initiate a natural language user interface associated with themonitor device 150. In such embodiments, the monitor device 150 can be,for example, a smart phone having a natural language user interface,such as, for example, Siri (from Apple) or any other “intelligentpersonal assistant.” The adapter can be configured to initiate the userinterface via the wireless connection by sending a signal. In someembodiments, the signal can be sent in response to a change in thestatus and/or configuration of the medicament delivery device and/or thesimulated medicament delivery device. In this manner, the adapter 120can initiate the interface to provide the user with additional resourcesduring a time of activity with the medicament delivery device and/or thesimulated medicament delivery device. Moreover, in such embodiments, theadapter 120 can also be configured to relay input to the user interfacevia the wireless connection between the adapter 120 and the monitordevice 150. For example, in some embodiments, a user can inputinformation via a microphone on the adapter 120 to send information tothe user interface of the monitor device 150.

In some embodiments, a computing device can send signals based on and/orproduced from a natural language interface that are received by amedicament delivery device, an adapter and/or a simulator of the typesshown and described herein. For example, a system can include acomputing device, such as a cell phone that has a natural languageinterface, and a medicament delivery device, such as a patch pump. Insuch embodiments, a user can provide voice commands to natural languageinterface of the cell phone. Such commands can include, for example,instructions to administer an additional dose, instructions to call ahealth-care professional or the like. In response, the cell phone cansend, via a wireless connection of the types shown and described herein,a signal to the medicament delivery device. The device can then executethe instructions. In this manner, the capability of the cell phone canbe leveraged to produce a voice-activated medicament delivery device.

Although the embodiments of FIGS. 40-42 are shown and described asreceiving a signal from an access control device 310, in otherembodiments, a user could enter a password PIN or other personallyidentifiable information to the kit 300 via a keyboard, touch screen,voice command and/or any other suitable device.

Although the kit 300 of FIGS. 40-42 is shown and described as containinga removable medicament container 360, in other embodiments, the kit 300can dispense a medicament directly, and/or can dispense a medicamentdelivery device.

Although the adapters 120 and 14240 are shown and described above areceiving at least a portion of a medicament delivery device (orsimulated medicament delivery device), any of the adapters describedherein can be coupled to a medicament delivery device (or simulatedmedicament delivery device) in any suitable manner. For example, in someembodiments, any of the adapters described herein can be coupled to amedicament delivery device (or simulated device) via only one side(i.e., the adapter does not “receive” a portion of the device). Forexample, in other embodiments, any of the adapters described herein canbe similar to the container shown and described with respect to the kit300. In yet other embodiments, the adapter can be a wall-mounted boxwithin which multiple medicament delivery devices, medicament containersand/or simulated medicament delivery devices can be stored.

Some embodiments described above include an adapter (or medicamentdelivery device) and a locator device operable to communicate with eachother and/or locate each other. The monitoring device and/or the locatordevice can communicate via Bluetooth®, WiFi, a cellular telephonenetwork, a satellite pager network, localized AM or FM radio signals,Broadcast AM, FM, or satellite radio, RFID signals, human audible orinaudible sound waves, IR, Zigbee™, X10, and/or any other suitablesignal. In some embodiments, the monitoring device and/or the locatordevice can be operable to locate any other device via, audible, visual,radio, GPS, and/or any other suitable location technique. The monitoringdevice and or the locator device can aid a user in locating a medicamentdelivery device by, for example, causing the medicament delivery deviceand/or the locator device to emit a audible, visual, and/or tactilealert. The alert can vary in power, frequency, and/or any other suitableparameter as the monitoring device and/or the locator device are broughtcloser to the medicament delivery device.

Any of the radios, transmitters, receivers, and/or transceiversdescribed herein can be operable to transmit, receive, repeat, and/orotherwise interact with electromagnetic signals. Electromagnetic signalscan be of any suitable frequency. For example, the radios, transmitters,receivers, and transceivers can be operable to transmit and/or receiveIEEE 802.11 signals, Bluetooth® signals, FM radio signals, AM radiosignals, cellular telephone signals, satellite pager signals, RFIDsignals, GPS signals, and/or any other suitable electromagnetic signal.

Although some of the embodiments described herein include one “masterdevice” (e.g., the monitoring device 150, which can be, for example, asmart phone) and one “slave device” (e.g., the adapter 120), in otherembodiments, devices and methods can include and/or establish a piconetincluding any suitable number of master devices and/or slave devices.For example, in some embodiments, a monitor device 150 can be configuredto establish a piconet with more than one adapter 120. In otherembodiments, a monitor device can be configured to establish a piconetwith an adapter 120 configured to receive a first medicament deliverydevice, a simulated medicament delivery device (or trainer) associatedwith the first medicament delivery device (e.g., a wireless-enabledtrainer of the types shown and described herein) and a second medicamentdelivery device (e.g., a wireless-enabled medicament delivery device).

In some embodiments, a medicament delivery device is shown and describedas an auto-injector. In other embodiments, the medicament deliverydevice can be a patch configured to adhere to the patient. The patch canrelease a medicament, for example, after receiving a signal that medicaltreatment is needed. The patch can receive the signal from, for example,a monitoring device. In other embodiments, the medicament deliverydevice can be an injector configured to be carried in a pocket of thepatient's garments. The injector can be configured to inject amedicament, for example, after receiving a signal that medical treatmentis needed.

In some embodiments, a locator device and/or a medicament deliverydevice can include an electronic circuit system and/or a sensor and beoperable to output an electronic output. Such a sensor can include, forexample, a proximity sensor (e.g., to determine the position of themedicament delivery device), a temperature sensor, a pressure sensor, anoptical sensor or the like. For example, in some embodiments, thecontainer can include a temperature sensor configured to sense thetemperature of the medicament contained within the medicament deliverydevice. In this manner, the electronic circuit system can output aninstruction and/or a status message when the medicament is too cold foreffective delivery. For example, in some embodiments, when themedicament is too cold for effective delivery or the delivery of a coldmedicament may cause unnecessary pain and discomfort (this may occur,for example, if the container is being used in an outdoor setting orrequires refrigeration prior to use), the electronic circuit system canoutput a message, such as, for example, “Medicament is too cold—allowmedicament to reach room temperature before using” and can alert theuser when the proper temperature has been reached.

Although in some embodiments the electronic circuit systems are shownand described above as outputting a single output in response to aninput (e.g., the removal of a medicament delivery device, the change inposition of a hinged lid, etc.), in other embodiments, an electroniccircuit system can output a sequence of electronic outputs in responseto such an input. In some embodiments, for example, when a medicamentdelivery device is removed from a container, an electronic circuitsystem can output a predetermined sequence of use instructions over apredetermined time period. For example, upon removing the medicamentdelivery device, the first instruction can be an audible outputindicating the type of medicament delivery device removed. After apredetermined time period, the electronic circuit system can then outputa second instruction, which can be a visual output instructing the userin how to diagnose the patient and/or prepare the patient for themedicament. In a similar manner, the electronic circuit system canprovide additional outputs to instruct the user in the use of themedicament delivery device. Moreover, in some embodiments, theelectronic circuit system can output an output instructing the user inpost-use procedures, such as for example, the disposal of the medicamentdelivery device, instructions for follow-up treatment or the like.

For example, although the electronic circuit systems are shown anddescribed above as being configured to output primarily audible andvisual outputs, in other embodiments, an electronic circuit system canbe configured to produce any suitable output. For example, in someembodiments, an electronic circuit system can produce a haptic output,such as a vibratory output produced by a piezo-electric actuator. Inother embodiments, an electronic circuit system can produce a thermaloutput, produced by a heating or cooling element.

Although some embodiments describe a recorded message output in English,in other embodiments, the electronic circuit system can output recordedspeech in any language. In yet other embodiments, the electronic circuitsystem can output recorded speech in multiple languages. In yet otherembodiments, the user can select the language in which the recordedspeech is to be output.

Medicament delivery devices shown and described above can be single-usemedical injectors, or any other suitable device for delivering one ormore doses of a medicament into a patient's body. For example, in someembodiments, a medicament delivery device can be a pen injectorcontaining multiple doses of a chronic-care medicament, such as, forexample, insulin. In such embodiments, an electronic circuit system canoutput instructions associated with not only an initial use of themedicament delivery device, but also associated with repeated uses,dosage monitoring or the like. In other embodiments, a medicamentdelivery device can include a transdermal medicament delivery device, awearable injector or pump that dispenses drug over several hours ordays, an inhaler or a nasal medicament delivery device.

Any of the monitoring devices, adapters and/or locators described hereincan be configured to send a signal in response to the detection of apotential emergency. For example, in some embodiments any of the devicesdescribed herein can be GPS-enabled, and can automatically dial anemergency number such as, for example, 911 (emergency dispatcher),and/or send information associated with the location of the deviceand/or the end user location through GPS satellite positioning ornetwork based positioning (using cell phone towers).

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, in some embodiments a kitcan include an electronic circuit system, two or more medicamentdelivery devices and a movable portion. In such embodiments, each of themedicament delivery devices can be associated with a switch. Moreover,the movable portion can also be associated with a switch. In thismanner, the electronic circuit system can be configured to output afirst electronic output when the movable portion is moved, a secondelectronic output when the first medicament delivery device is removedfrom the container and a third electronic output when the secondmedicament delivery device is removed from the container.

As another example, although some embodiments are described as having aprocessor, a radio, a sensor, etc. disposed on an adapter and/or acover, devices, structures, and/or modules associated with adaptersand/or covers can be disposed on any suitable device. For example, insome embodiments, a housing of a medicament delivery device or simulatedmedicament delivery device can include a processor and/or radio.Similarly, some embodiments describe a kit having a processor, audibleoutput, etc. Any devices, structures, and/or modules associated with akit, however, can be associated with an adapter, cover, medicamentdelivery device, and/or simulated medicament delivery device.

The medicament delivery devices described herein, such as the medicamentdelivery device 100, the medicament delivery device 21990 and any othersdescribed herein, can be any suitable medicament delivery device. Forexample, a medicament delivery device according to an embodiment caninclude a pen injector, an auto-injector, a wearable injector or pumpthat dispenses drug over several hours or days, an inhaler or atransdermal delivery device. Where medicament delivery devices aredescribed, it should be understood that alternative embodimentsincluding a simulated medicament delivery device are possible, forexample, the simulated medicament delivery devices shown and describedin U.S. patent application Ser. No. 11/679,331 (and Patent PublicationNo. 2008/0059133), entitled “Medical Injector Simulation Device” filedFeb. 27, 2007, the disclosure of which is incorporated herein byreference in its entirety. A simulated medicament delivery device may besuitable to train a user in the operation of a medicament device.

The simulated medicament delivery device can simulate the actualmedicament delivery device in any number of ways. For example, in someembodiments, the simulated medicament delivery device can have a shapecorresponding to a shape of the actual medicament delivery device, asize corresponding to a size of the actual medicament delivery deviceand/or a weight corresponding to a weight of the actual medicamentdelivery device. Moreover, in some embodiments, the simulated medicamentdelivery device can include components that correspond to the componentsof the actual medicament delivery device. In this manner, the simulatedmedicament delivery device can simulate the look, feel and sounds of theactual medicament delivery device. For example, in some embodiments, thesimulated medicament delivery device can include external components(e.g., a housing, a needle guard, a sterile cover, a safety lock or thelike) that correspond to external components of the actual medicamentdelivery device. In some embodiments, the simulated medicament deliverydevice can include internal components (e.g., an actuation mechanism, acompressed gas source, a medicament container or the like) thatcorrespond to internal components of the actual medicament deliverydevice.

In some embodiments, however, the simulated medicament delivery devicecan be devoid of a medicament and/or those components that cause themedicament to be delivered (e.g., a needle, a nozzle or the like). Inthis manner, the simulated medicament delivery device can be used totrain a user in the use of the actual medicament delivery device withoutexposing the user to a needle and/or a medicament. Moreover, thesimulated medicament delivery device can have features to identify it asa training device to prevent a user from mistakenly believing that thesimulated medicament delivery device can be used to deliver amedicament. For example, in some embodiments, the simulated medicamentdelivery device can be of a different color than a corresponding actualmedicament delivery device. Similarly, in some embodiments, thesimulated medicament delivery device can include a label clearlyidentifying it as a training device.

In some embodiments the medicament delivery devices and/or medicamentcontainers shown herein can include any suitable medicament, such as avaccine. Such vaccines can include, for example, an influenza A vaccine,an influenza B vaccine, an influenza A (H1N1) vaccine, a hepatitis Avaccine, a hepatitis B vaccine, a haemophilus influenza Type B (HiB)vaccine, a measles vaccine, a mumps vaccine, a rubella vaccine, a poliovaccine, a human papilloma virus (HPV) vaccine, a tetanus vaccine, adiphtheria vaccine, a pertussis vaccine, a bubonic plague vaccine, ayellow fever vaccine, a cholera vaccine, a malaria vaccine, a cancervaccine, a smallpox vaccine, a pneumococcal vaccine, a rotavirusvaccine, a varicella vaccine, a meningococcus vaccine and/or anycombination thereof (e.g. tetanus, diphtheria and pertussis vaccine). Inother embodiments, the medicament delivery devices and/or medicamentcontainers shown herein can include epinephrine. In other embodiments,the medicament contained within any of the medicament delivery devicesand/or medicament containers shown herein can be naloxone, including anyof the naloxone formulations described in U.S. Pat. No. 8,627,816,entitled “Medicament Delivery Device for Administration of OpioidAntagonists Including Formulation for Naloxone,” filed on Feb. 28, 2011.

In other embodiments, the medicament contained within any of themedicament delivery devices and/or medicament containers shown hereincan include insulin, glucagon, human growth hormone (HGH),erythropoiesis-stimulating agents, adalimumab, other monoclonalAntibodies (mAbs′), Interferon and other chronic therapies, or the like.Such formulations can be produced using a general lyophilization processwith glucagon (of recombinant or synthetic origin) using bulking agents,stabilizers, buffers, acidifying agents or other excipients comprisingof, but not limited to, one or more of the following combinations:lactose, hydrochloric acid; glucose, histidine, hydrochloric acid;trehalose, mannitol, citrate; trehalose, mannitol, hydrochloric acid;trehalose, glycine, hydrochloric acid; Mannitol, ascorbic acid; andGlycine, hydrochloric acid.

In other embodiments any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject medicament formulations, including lyophilized biologics and/orbiopharmaceuticals, such as, for example, canakinumab, certolizumab,golimumab, and/or interleukins, for the treatment of crypyrin associatedperiodic syndromes, hereditary andioedema, and other auto-immunediseases. In yet other embodiments, any of the medicament deliverydevices and/or medicament containers described herein can be filled withand/or used to inject intranasal medicaments including small moleculessuch as epinephrine, naloxone, diazepam, midazolam, lorazepam orbiologics, such as glucagon or human growth hormone, formulated for usein an auto injector, for the treatment of musculoskeletal diseases,growth disorders, diabetes or other disorders. Thus, although themedicament delivery devices shown herein are primarily injectors, inother embodiments, a medicament delivery device need not be a medicalinjector, but rather, can be an inhaler, a wearable pump, an intranasaldelivery device or the like.

In other embodiments, any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject an anti-thrombolytic, such as LMWH, ULMWH, Xa Inhibitors,biotinylated idraparinux, etc., for either the acute management and/orsurgical prophylaxis of deep vein thrombosis and/or pulmonary embolismor for the management of other conditions which may requireanticoagulation to prevent thromboembolism, such as its use incardiovascular diseases including atrial fibrillation and ischemicstroke. In another example, in some embodiments an injector according toan embodiment can be filled with and/or used to inject formulations forthe treatment of asthma and/or chronic obstructive pulmonary disease.

In other embodiments, any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject recombinant hyaluronidase.

In other embodiments, any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject depot medroxyprogesterone acetate for the treatment ofinfertility.

In other embodiments, any of the injectors described herein can befilled with and/or used to inject Benzodiazepines such as Midazolam,Anticoagulants, Hematopoietic agents, Adrenocortical steroids,Antidiabetic agents, Sex hormones, Somatostatin Analogs, MonoclonalAntibodies, Agents for Migraine, Antianxiety Agents,Antiemetic/Antivertigo Agents, Antipsychotic Agents, GeneralAnesthetics, NSAIDs, Opioid Agonist-Antagonist, Opioid Analgesics,Skeletal Muscle Relaxants Aminoglycosides, Antiprotozoals,Antiretroviral Agents, Antituberculosis Agents, Bacitracin,Cephalosporin and Related Antibiotics, Colistimethate sodium,Lincosamides, Monobactams, Penicillins, Polymyxin B Sulfate,Antirheumatologic Agents, Antimetabolites, Immune Globulins, ImmulogicAgents, Monoclonal antibodies, Antimetabolites, Hematopoietic, and/orHemin, and agents that block proprotein convertase subtilisin/kexin type9 (PCSK9).

In other embodiments, any of the medicament delivery devices and/ormedicament containers described herein can be filled with and/or used toinject environmental, food, and household allergen formulations for thetreatment of allergic disease, specifically for use in immunotherapy.

In still other embodiments, the medicament contained within any of themedicament delivery devices and/or medicament containers shown hereincan be a placebo substance (i.e., a substance with no activeingredients), such as water.

The medicament containers and/or medicament delivery devices disclosedherein can contain any suitable amount of any medicament. For example,in some embodiments, a medicament delivery device as shown herein can bea single-dose device containing an amount medicament to be delivered ofapproximately 0.4 mg, 0.8 mg, 1 mg, 1.6 mg or 2 mg. As described above,the fill volume can be such that the ratio of the delivery volume to thefill volume is any suitable value (e.g., 0.4, 0.6 or the like). In someembodiments, an electronic circuit system can include a “configurationswitch” (similar to any of the switches shown and described above, suchas the switch 6972) that, when actuated during the assembly of thedelivery device, can select an electronic output corresponding to thedose contained within the medicament container. In addition, in the caseof multiple-dose delivery, the user can activate via physical movement,voice command or the like a switch located on the medicament deliverydevice in order to select the specific dose required

1. An apparatus, comprising: a medicament delivery device; and anelectronic circuit system including a radio configured to electronicallycommunicate with a computing device via a wireless protocol, the radioconfigured to send a first signal characterized by a first communicationinterval when the medicament delivery device is in a firstconfiguration, the radio configured to send a second signalcharacterized by a second communication interval when the medicamentdelivery device is in a second configuration, the second communicationinterval different from the first communication interval.
 2. Theapparatus of claim 1, wherein the second communication interval is atleast one of an advertising interval, a hold duration period, a sniffinterval or a park mode beacon period.
 3. The apparatus of claim 1,wherein: the first communication interval is associated with a firstcommunication mode between the electronic circuit system and thecomputing device; and the second communication interval is associatedwith a second communication mode between the electronic circuit systemand the computing device, the second communication mode different thanthe first communication mode.
 4. The apparatus of claim 1, wherein: thefirst communication interval is associated with a communication latencybetween the electronic circuit system and the computing device ofgreater than about one second; and the second communication interval isassociated with a communication latency between the electronic circuitsystem and the computing device of less than about one second.
 5. Theapparatus of claim 1, wherein: the electronic circuit system includes asensor configured to produce an indication when the medicament deliverydevice transitions from the first configuration to the secondconfiguration, the radio configured to send the second signal inresponse to the indication.
 6. The apparatus of claim 5, wherein thesensor is at least one of a contact sensor, a switch, a microphone, acapacitance sensor or an optical sensor.
 7. The apparatus of claim 1,wherein: the electronic circuit system includes a sensor and acommunication module, the communication module implemented in at leastone of a memory or a processing device, the sensor configured to producean indication when the medicament delivery device transitions from thefirst configuration to the second configuration, the communicationmodule configured to determine, based on the transition information, thesecond communication interval.
 8. The apparatus of claim 1, wherein: themedicament delivery device is an auto-injector having an actuatorconfigured to initiate delivery of a medicament and a lock memberconfigured to limit movement of the actuator, the lock member in a firstposition relative to the actuator when the medicament delivery device isin the first configuration, the lock member in a second positionrelative to the actuator when the medicament delivery device is in thesecond configuration.
 9. The apparatus of claim 1, wherein: themedicament delivery device is configured to produce a sound when themedicament delivery device is transitioned from the first configurationto the second configuration; the electronic circuit system includes amicrophone configured to produce an indication in response to the sound;and the radio is configured to send the second signal in response to theindication.
 10. The apparatus of claim 1, further comprising: an adapterconfigured to receive at least a portion the medicament delivery device,the electronic circuit system being coupled to the adapter, the portionof the medicament delivery device being within the adapter when themedicament delivery device is in the first configuration, the portion ofthe medicament delivery device being outside of the adapter when themedicament delivery device is in the second configuration.
 11. Theapparatus of claim 1, wherein: the electronic circuit system includes asensor configured to produce an indication when the medicament deliverydevice transitions from the first configuration to the secondconfiguration; and the radio is configured to send a third signal toinitiate a natural language user interface associated with the computingdevice in response to the indication. 12-26. (canceled)
 27. Anapparatus, comprising: a radio configured to electronically communicatewith a computing device via a wireless protocol, the radio configured tosend a first wireless signal associated with a first communicationsignal and a second wireless signal associated with a secondcommunication signal; a memory configured to store transitioninformation associated with a transition of a medicament delivery devicefrom a first configuration to a second configuration; and acommunication module implemented in at least one of the memory or aprocessing device, the communication module configured to receive thetransition information and determine, based on the transitioninformation, at least the second communication interval.
 28. The methodof claim 27, wherein the second communication interval is at least oneof an advertising interval, a hold duration period, a sniff interval ora park mode beacon period.
 29. The apparatus of claim 27, wherein: thefirst communication interval is associated with a first communicationmode between the radio and the computing device; and the secondcommunication interval is associated with a second communication modebetween the radio and the computing device, the second communicationmode different than the first communication mode.
 30. The apparatus ofclaim 27, wherein: the memory is configured to store actuationinformation associated with an actuation of the medicament deliverydevice; and the communication module configured to receive the actuationinformation and produce, based on the actuation information, a datasignal.
 31. The apparatus of claim 30, wherein: at least one of thefirst wireless signal or the second wireless signal is associated with afirst radio frequency channel; and the radio is configured to send athird wireless signal associated with the data signal produce, the thirdwireless signal associated with a second radio frequency channel, thesecond radio frequency channel different from the first radio frequencychannel. 32-54. (canceled)
 55. A method, comprising: receiving anindication associated with an operation from a plurality of operationsassociated with a simulated medicament delivery device; producing, inresponse to the indication, a recorded speech output associated with afirst training script; updating, in response to the indication, useinformation associated with the plurality of operations associated withthe simulated medicament delivery device; and producing, in response tothe updated use information, a second training script.
 56. The method ofclaim 55, wherein the indication is a first indication received at afirst time, the method further comprising: receiving, at a second time,a second indication associated with the operation from the plurality ofoperations associated with the simulated medicament delivery device; andproducing, in response to the second indication, a recorded speechoutput associated with the second training script.
 57. The method ofclaim 55, wherein the updating includes at least one of overwriting theuse information stored in a memory or appending to the use informationstored in the memory.
 58. The method of claim 55, wherein the useinformation includes at least one of a time associated with thereceiving the indication, a number of times the operation from theplurality of operations has been performed or a sequence associated withthe plurality of operations.
 59. The method of claim 55, wherein theoperation from the plurality of operations include at least one ofremoving the simulated medicament delivery device from an adapter,removing a safety lock from the simulated medicament delivery device,orienting the simulated medicament delivery device or actuating thesimulated medicament delivery device.
 60. The method of claim 55,further comprising: producing a wireless signal in response to theindication.
 61. The method of claim 55, wherein the simulated medicamentdelivery device is configured to simulate any one of an auto-injector, ajet injector, a pen injector, a syringe, a nasal delivery device or aninhaler.
 62. An apparatus, comprising: an audible output device coupledto at least one of a medicament delivery device or a simulatedmedicament delivery device, the audible output device configured toproduce an audible output associated with a first script in response toan operation from a plurality of operations associated with themedicament delivery device or the simulated medicament delivery device;a memory configured to store use information associated with theplurality of operations; and a use module implemented in at least one ofthe memory or a processing device, the use module configured to update,in response to the operation from the plurality of operations, useinformation associated with the plurality of operations, the use moduleconfigured to produce a second script based on the updated useinformation.
 63. The apparatus of claim 62, further comprising; a radioconfigured to electronically communicate with a computing device via awireless protocol, the radio configured to send a wireless signal inresponse to the operation from the plurality of operations.
 64. Theapparatus of claim 62, wherein use information includes at least one ofa time associated with the receiving the indication, a number of timesthe operation from the plurality of operations has been performed or asequence associated with the plurality of operations.
 65. The apparatusof claim 62, wherein: the medicament delivery device is any one of anauto-injector, a jet injector, a pen injector, a bolus injector, awearable pump, a patch pump, a wearable injector, a syringe, a nasaldelivery device or an inhaler; and the simulated medicament deliverydevice is configured to simulate the medicament delivery device and isdevoid a medicament. 66-73. (canceled)